Trial Outcomes & Findings for Phase I Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of BVD-523 in Patients With Advanced Malignancies (NCT NCT01781429)
NCT ID: NCT01781429
Last Updated: 2020-03-20
Results Overview
DLT is defined as any BVD-523 related toxicity in the first 21 days of treatment that results in: 1. ≥Grade 4 hematologic toxicity for \>1 day; 2. Grade 3 hematologic toxicity with complications e.g., thrombocytopenia with bleeding; 3. ≥Grade 3 non-hematologic toxicity, except untreated nausea, vomiting, constipation, pain and rash (these become DLTs if the adverse event (AE) persists despite adequate treatment), a doubling of aspartate transaminase (AST)/alanine transaminase (ALT) in patients with grade 2 ALT/AST at baseline; 4. A treatment interruption exceeding 5 days (or an interruption exceeding 7 days for rash, despite adequate treatment) in Cycle 1 (or inability to begin Cycle 2 for \> 7 days) due to BVD-523-related toxicity.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
136 participants
Primary outcome timeframe
As indicated by safety and tolerability during study conduct; ~42 months
Results posted on
2020-03-20
Participant Flow
Participant milestones
| Measure |
Dose-escalation 10mg b.i.d. Cohort
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.
|
Dose-escalation 20mg b.i.d. Cohort
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.
|
Dose-escalation 40mg b.i.d. Cohort
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.
|
Dose-escalation 75mg b.i.d. Cohort
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.
|
Dose-escalation 150mg b.i.d. Cohort
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.
|
Dose-escalation 300mg b.i.d. Cohort
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.
|
Dose-escalation 600mg b.i.d. Cohort
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.
|
Dose-escalation 750mg b.i.d. Cohort
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.
|
Dose-escalation 900mg b.i.d. Cohort
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.
|
Cohort-expansion Group 1
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.
|
Cohort-expansion Group 2
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.
|
Cohort-expansion Group 3
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.
|
Cohort-expansion Group 4
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.
|
Cohort-expansion Group 5
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.
|
Cohort-expansion Group 6
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.
|
Cohort-expansion Group 7
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
1
|
1
|
4
|
7
|
4
|
7
|
24
|
18
|
21
|
22
|
8
|
16
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
1
|
1
|
4
|
7
|
4
|
7
|
24
|
18
|
21
|
22
|
8
|
16
|
0
|
Reasons for withdrawal
| Measure |
Dose-escalation 10mg b.i.d. Cohort
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.
|
Dose-escalation 20mg b.i.d. Cohort
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.
|
Dose-escalation 40mg b.i.d. Cohort
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.
|
Dose-escalation 75mg b.i.d. Cohort
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.
|
Dose-escalation 150mg b.i.d. Cohort
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.
|
Dose-escalation 300mg b.i.d. Cohort
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.
|
Dose-escalation 600mg b.i.d. Cohort
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.
|
Dose-escalation 750mg b.i.d. Cohort
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.
|
Dose-escalation 900mg b.i.d. Cohort
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.
|
Cohort-expansion Group 1
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.
|
Cohort-expansion Group 2
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.
|
Cohort-expansion Group 3
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.
|
Cohort-expansion Group 4
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.
|
Cohort-expansion Group 5
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.
|
Cohort-expansion Group 6
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.
|
Cohort-expansion Group 7
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
1
|
1
|
5
|
2
|
3
|
0
|
|
Overall Study
Disease Progression
|
1
|
0
|
1
|
1
|
1
|
4
|
7
|
4
|
6
|
15
|
15
|
15
|
15
|
4
|
11
|
0
|
|
Overall Study
Unacceptable Toxicity
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Patient Condition Changed
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Other - as entered by PI in eCRF
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
2
|
1
|
1
|
1
|
0
|
|
Overall Study
Enrolled, but not treated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Phase I Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of BVD-523 in Patients With Advanced Malignancies
Baseline characteristics by cohort
| Measure |
Dose-escalation 10mg b.i.d. Cohort
n=1 Participants
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.
|
Dose-escalation 20mg b.i.d. Cohort
n=1 Participants
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.
|
Dose-escalation 40mg b.i.d. Cohort
n=1 Participants
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.
|
Dose-escalation 75mg b.i.d. Cohort
n=1 Participants
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.
|
Dose-escalation 150mg b.i.d. Cohort
n=1 Participants
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.
|
Dose-escalation 300mg b.i.d. Cohort
n=4 Participants
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.
|
Dose-escalation 600mg b.i.d. Cohort
n=7 Participants
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.
|
Dose-escalation 750mg b.i.d. Cohort
n=4 Participants
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.
|
Dose-escalation 900mg b.i.d. Cohort
n=7 Participants
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.
|
Cohort-expansion Group 1
n=24 Participants
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.
|
Cohort-expansion Group 2
n=17 Participants
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.
|
Cohort-expansion Group 3
n=21 Participants
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.
|
Cohort-expansion Group 4
n=22 Participants
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.
|
Cohort-expansion Group 5
n=8 Participants
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.
|
Cohort-expansion Group 6
n=16 Participants
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
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
12 Participants
n=64 Participants
|
7 Participants
n=17 Participants
|
16 Participants
n=21 Participants
|
11 Participants
n=22 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=16 Participants
|
72 Participants
n=135 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
12 Participants
n=64 Participants
|
10 Participants
n=17 Participants
|
5 Participants
n=21 Participants
|
11 Participants
n=22 Participants
|
2 Participants
n=8 Participants
|
10 Participants
n=16 Participants
|
63 Participants
n=135 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
8 Participants
n=64 Participants
|
7 Participants
n=17 Participants
|
9 Participants
n=21 Participants
|
5 Participants
n=22 Participants
|
1 Participants
n=8 Participants
|
9 Participants
n=16 Participants
|
52 Participants
n=135 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
16 Participants
n=64 Participants
|
10 Participants
n=17 Participants
|
12 Participants
n=21 Participants
|
17 Participants
n=22 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=16 Participants
|
83 Participants
n=135 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
3 Participants
n=135 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
19 Participants
n=64 Participants
|
15 Participants
n=17 Participants
|
21 Participants
n=21 Participants
|
16 Participants
n=22 Participants
|
8 Participants
n=8 Participants
|
15 Participants
n=16 Participants
|
121 Participants
n=135 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=16 Participants
|
11 Participants
n=135 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
6 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=16 Participants
|
6 Participants
n=135 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
19 Participants
n=64 Participants
|
15 Participants
n=17 Participants
|
20 Participants
n=21 Participants
|
18 Participants
n=22 Participants
|
6 Participants
n=8 Participants
|
15 Participants
n=16 Participants
|
117 Participants
n=135 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
6 Participants
n=135 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
4 participants
n=10 Participants
|
7 participants
n=115 Participants
|
4 participants
n=6 Participants
|
7 participants
n=6 Participants
|
24 participants
n=64 Participants
|
17 participants
n=17 Participants
|
21 participants
n=21 Participants
|
22 participants
n=22 Participants
|
8 participants
n=8 Participants
|
16 participants
n=16 Participants
|
135 participants
n=135 Participants
|
PRIMARY outcome
Timeframe: As indicated by safety and tolerability during study conduct; ~42 monthsDLT is defined as any BVD-523 related toxicity in the first 21 days of treatment that results in: 1. ≥Grade 4 hematologic toxicity for \>1 day; 2. Grade 3 hematologic toxicity with complications e.g., thrombocytopenia with bleeding; 3. ≥Grade 3 non-hematologic toxicity, except untreated nausea, vomiting, constipation, pain and rash (these become DLTs if the adverse event (AE) persists despite adequate treatment), a doubling of aspartate transaminase (AST)/alanine transaminase (ALT) in patients with grade 2 ALT/AST at baseline; 4. A treatment interruption exceeding 5 days (or an interruption exceeding 7 days for rash, despite adequate treatment) in Cycle 1 (or inability to begin Cycle 2 for \> 7 days) due to BVD-523-related toxicity.
Outcome measures
| Measure |
Dose-escalation 10mg b.i.d. Cohort
n=1 Participants
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.
|
Dose-escalation 20mg b.i.d. Cohort
n=1 Participants
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.
|
Dose-escalation 40mg b.i.d. Cohort
n=1 Participants
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.
|
Dose-escalation 75mg b.i.d. Cohort
n=1 Participants
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.
|
Dose-escalation 150mg b.i.d. Cohort
n=1 Participants
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.
|
Dose-escalation 300mg b.i.d. Cohort
n=4 Participants
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.
|
Dose-escalation 600mg b.i.d. Cohort
n=7 Participants
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.
|
Dose-escalation 750mg b.i.d. Cohort
n=4 Participants
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.
|
Dose-escalation 900mg b.i.d. Cohort
n=7 Participants
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.
|
Cohort-expansion Group 1
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.
|
Cohort-expansion Group 2
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.
|
Cohort-expansion Group 3
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.
|
Cohort-expansion Group 4
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.
|
Cohort-expansion Group 5
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.
|
Cohort-expansion Group 6
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Determination of Recommended Phase 2 Dose (RP2D) of BVD-523 by Dose-limiting Toxicities (DLT).
Any DLT · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of Recommended Phase 2 Dose (RP2D) of BVD-523 by Dose-limiting Toxicities (DLT).
Grade 3 Hematologic Toxicity with Complications · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of Recommended Phase 2 Dose (RP2D) of BVD-523 by Dose-limiting Toxicities (DLT).
Grade 3 Hematologic Toxicity with Complications · No
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of Recommended Phase 2 Dose (RP2D) of BVD-523 by Dose-limiting Toxicities (DLT).
≥Grade 3 Non-Hematologic Toxicity · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of Recommended Phase 2 Dose (RP2D) of BVD-523 by Dose-limiting Toxicities (DLT).
Any DLT · No
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of Recommended Phase 2 Dose (RP2D) of BVD-523 by Dose-limiting Toxicities (DLT).
≥Grade 3 Non-Hematologic Toxicity · No
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples will be collected on day 1 and day 15 of Cycle 1Population: Day 1 - Dose-escalation 10mg b.i.d. patient was not calculable. Cohort-expansion numbers do not include those patients that were dose reduced and/or were not at a steady state with 600mg b.i.d. for the Day 15 draw.
Data provided is for BVD-523.
Outcome measures
| Measure |
Dose-escalation 10mg b.i.d. Cohort
n=1 Participants
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.
|
Dose-escalation 20mg b.i.d. Cohort
n=1 Participants
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.
|
Dose-escalation 40mg b.i.d. Cohort
n=1 Participants
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.
|
Dose-escalation 75mg b.i.d. Cohort
n=1 Participants
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.
|
Dose-escalation 150mg b.i.d. Cohort
n=1 Participants
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.
|
Dose-escalation 300mg b.i.d. Cohort
n=4 Participants
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.
|
Dose-escalation 600mg b.i.d. Cohort
n=7 Participants
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.
|
Dose-escalation 750mg b.i.d. Cohort
n=4 Participants
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.
|
Dose-escalation 900mg b.i.d. Cohort
n=7 Participants
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.
|
Cohort-expansion Group 1
n=24 Participants
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.
|
Cohort-expansion Group 2
n=18 Participants
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.
|
Cohort-expansion Group 3
n=21 Participants
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.
|
Cohort-expansion Group 4
n=22 Participants
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.
|
Cohort-expansion Group 5
n=8 Participants
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.
|
Cohort-expansion Group 6
n=16 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Characterization of the Time Versus Plasma Concentration Profiles of BVD-523 and Selected Metabolites.
Cmax Day 1
|
NA ng/mL
Day 1 - Dose-escalation 10mg b.i.d. patient was not calculable.
|
14.9 ng/mL
|
100 ng/mL
|
133 ng/mL
|
216 ng/mL
|
765 ng/mL
Standard Deviation 234
|
1110 ng/mL
Standard Deviation 589
|
1450 ng/mL
Standard Deviation 539
|
1430 ng/mL
Standard Deviation 1010
|
1180 ng/mL
Standard Deviation 501
|
1260 ng/mL
Standard Deviation 474
|
1190 ng/mL
Standard Deviation 467
|
1230 ng/mL
Standard Deviation 840
|
1140 ng/mL
Standard Deviation 423
|
1560 ng/mL
Standard Deviation 885
|
|
Characterization of the Time Versus Plasma Concentration Profiles of BVD-523 and Selected Metabolites.
Cmax Day 15
|
45.7 ng/mL
|
15.8 ng/mL
|
191 ng/mL
|
326 ng/mL
|
459 ng/mL
|
586 ng/mL
Standard Deviation 257
|
3090 ng/mL
Standard Deviation 1570
|
2290 ng/mL
Standard Deviation 1790
|
1730 ng/mL
Standard Deviation 401
|
2440 ng/mL
Standard Deviation 900
|
1890 ng/mL
Standard Deviation 953
|
2340 ng/mL
Standard Deviation 962
|
1890 ng/mL
Standard Deviation 1060
|
2050 ng/mL
Standard Deviation 1570
|
2680 ng/mL
Standard Deviation 1520
|
SECONDARY outcome
Timeframe: Patients will be evaluated at baseline & at periodic follow-up visits through the time their participation in the study is completion. The best responses presented occurred at different time points for each patient.At enrollment, all study patients had metastatic or advanced-stage malignant tumor for which no curative therapy was known to exist. Patients entering Part 2 additionally had to have measurable disease by RECIST version 1.1. Data shown is best response.
Outcome measures
| Measure |
Dose-escalation 10mg b.i.d. Cohort
n=1 Participants
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.
|
Dose-escalation 20mg b.i.d. Cohort
n=1 Participants
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.
|
Dose-escalation 40mg b.i.d. Cohort
n=1 Participants
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.
|
Dose-escalation 75mg b.i.d. Cohort
n=1 Participants
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.
|
Dose-escalation 150mg b.i.d. Cohort
n=1 Participants
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.
|
Dose-escalation 300mg b.i.d. Cohort
n=4 Participants
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.
|
Dose-escalation 600mg b.i.d. Cohort
n=7 Participants
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.
|
Dose-escalation 750mg b.i.d. Cohort
n=4 Participants
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.
|
Dose-escalation 900mg b.i.d. Cohort
n=7 Participants
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.
|
Cohort-expansion Group 1
n=22 Participants
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.
|
Cohort-expansion Group 2
n=13 Participants
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.
|
Cohort-expansion Group 3
n=15 Participants
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.
|
Cohort-expansion Group 4
n=19 Participants
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.
|
Cohort-expansion Group 5
n=5 Participants
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.
|
Cohort-expansion Group 6
n=14 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Clinical Evidence of Tumor Response Assessed by Physical or Radiological Exam.
Progressive Disease
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
9 Participants
|
3 Participants
|
2 Participants
|
|
Clinical Evidence of Tumor Response Assessed by Physical or Radiological Exam.
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Evidence of Tumor Response Assessed by Physical or Radiological Exam.
Partial Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Clinical Evidence of Tumor Response Assessed by Physical or Radiological Exam.
Stable Disease
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
14 Participants
|
8 Participants
|
6 Participants
|
7 Participants
|
2 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Patients will be evaluated at baseline and on ~day 15 of Cycle 1Population: The protocol was amended to stop collecting PD samples unless the patient consented to a tumor biopsy. Therefore, some patients did not have PD samples collected or did not consent to optional research tests involving collection of tumor tissue and blood/plasma samples.
RSK1, a member of the RSK serine/threonine kinase family, is a direct substrate of the MAP Kinases ERK1 \& ERK2. RSK1 and ERK1/2 form an inactive complex in unstimulated cells. Upon activation of the mitogenic pathway, ERK1/2 phosphorylates Thr573, Thr359 and Ser363 on RSK1. Thr573 resides in the activation loop of the carboxy terminal kinase domain of RSK1 and once phosphorylated, enables RSK1 to autophosphorylate Ser380. Phosphorylation of Ser380 on RSK1 can therefore be used as a target biomarker for ERK1 and ERK2 activity. BVD-523 inhibits the activity of ERK. In this study, phosphorylation of RSK1 Ser 380 (pRSK) was used as a target biomarker for assessment of ERK inhibition by BVD-523 in human whole blood samples.
Outcome measures
| Measure |
Dose-escalation 10mg b.i.d. Cohort
n=24 Participants
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.
|
Dose-escalation 20mg b.i.d. Cohort
n=17 Participants
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.
|
Dose-escalation 40mg b.i.d. Cohort
n=21 Participants
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.
|
Dose-escalation 75mg b.i.d. Cohort
n=22 Participants
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.
|
Dose-escalation 150mg b.i.d. Cohort
n=8 Participants
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.
|
Dose-escalation 300mg b.i.d. Cohort
n=16 Participants
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.
|
Dose-escalation 600mg b.i.d. Cohort
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.
|
Dose-escalation 750mg b.i.d. Cohort
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.
|
Dose-escalation 900mg b.i.d. Cohort
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.
|
Cohort-expansion Group 1
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.
|
Cohort-expansion Group 2
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.
|
Cohort-expansion Group 3
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.
|
Cohort-expansion Group 4
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.
|
Cohort-expansion Group 5
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.
|
Cohort-expansion Group 6
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamic (PD) Response Measured as Percentage Enzyme Inhibition of RSK1 Ser 380 (pRSK)
Cycle 1, Day 1; 4 hours post-dose
|
82.162 Enzyme inhibition (%)
Standard Deviation 27.3012
|
69.989 Enzyme inhibition (%)
Standard Deviation 36.9362
|
87.563 Enzyme inhibition (%)
Standard Deviation 26.8634
|
96.868 Enzyme inhibition (%)
Standard Deviation 5.8054
|
93.910 Enzyme inhibition (%)
Standard Deviation 12.1800
|
80.214 Enzyme inhibition (%)
Standard Deviation 28.9393
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacodynamic (PD) Response Measured as Percentage Enzyme Inhibition of RSK1 Ser 380 (pRSK)
Cycle 1, Day 1; pre-dose
|
0.000 Enzyme inhibition (%)
Standard Deviation 0
|
0.000 Enzyme inhibition (%)
Standard Deviation 0
|
0.000 Enzyme inhibition (%)
Standard Deviation 0
|
0.000 Enzyme inhibition (%)
Standard Deviation 0
|
0.000 Enzyme inhibition (%)
Standard Deviation 0
|
0.000 Enzyme inhibition (%)
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacodynamic (PD) Response Measured as Percentage Enzyme Inhibition of RSK1 Ser 380 (pRSK)
Cycle 1, Day 15; pre-dose
|
94.607 Enzyme inhibition (%)
Standard Deviation 9.9291
|
66.667 Enzyme inhibition (%)
Standard Deviation 57.7350
|
78.679 Enzyme inhibition (%)
Standard Deviation 37.6286
|
91.955 Enzyme inhibition (%)
Standard Deviation 21.5915
|
89.050 Enzyme inhibition (%)
Standard Deviation 18.9660
|
99.447 Enzyme inhibition (%)
Standard Deviation 1.4627
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacodynamic (PD) Response Measured as Percentage Enzyme Inhibition of RSK1 Ser 380 (pRSK)
Cycle 1, Day 15; 4 hours post-dose
|
91.419 Enzyme inhibition (%)
Standard Deviation 13.9282
|
56.554 Enzyme inhibition (%)
Standard Deviation 51.2962
|
87.624 Enzyme inhibition (%)
Standard Deviation 26.0916
|
98.902 Enzyme inhibition (%)
Standard Deviation 3.4722
|
92.640 Enzyme inhibition (%)
Standard Deviation 12.7479
|
85.329 Enzyme inhibition (%)
Standard Deviation 27.2781
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Dose-escalation 10mg b.i.d. Cohort
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose-escalation 20mg b.i.d. Cohort
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose-escalation 40mg b.i.d. Cohort
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose-escalation 75mg b.i.d. Cohort
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose-escalation 150mg b.i.d. Cohort
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose-escalation 300mg b.i.d. Cohort
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose-escalation 600mg b.i.d. Cohort
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Dose-escalation 750mg b.i.d. Cohort
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose-escalation 900mg b.i.d. Cohort
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort-expansion
Serious events: 57 serious events
Other events: 107 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Dose-escalation 10mg b.i.d. Cohort
n=1 participants at risk
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.
|
Dose-escalation 20mg b.i.d. Cohort
n=1 participants at risk
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.
|
Dose-escalation 40mg b.i.d. Cohort
n=1 participants at risk
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
|
Dose-escalation 75mg b.i.d. Cohort
n=1 participants at risk
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.
|
Dose-escalation 150mg b.i.d. Cohort
n=1 participants at risk
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.
|
Dose-escalation 300mg b.i.d. Cohort
n=4 participants at risk
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.
|
Dose-escalation 600mg b.i.d. Cohort
n=7 participants at risk
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.
|
Dose-escalation 750mg b.i.d. Cohort
n=4 participants at risk
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.
|
Dose-escalation 900mg b.i.d. Cohort
n=7 participants at risk
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.
|
Cohort-expansion
n=108 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
28.6%
2/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
5.6%
6/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
DIVERTICULUM
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
General disorders
DISEASE PROGRESSION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
8.3%
9/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
General disorders
PYREXIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
4.6%
5/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
General disorders
ASTHENIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
General disorders
FATIGUE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
BACTERAEMIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
28.6%
2/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
28.6%
2/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
3.7%
4/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL CANCER
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Nervous system disorders
CEREBELLAR INFARCTION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
LARGE INTESTINAL ULCER
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
PERITONEAL HAEMORRHAGE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
RETROPERITONEAL HAEMORRHAGE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
General disorders
CHEST PAIN
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
General disorders
DEATH
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
2.8%
3/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
FUNGAEMIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Respiratory, thoracic and mediastinal disorders
STRIDOR
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Metabolism and nutrition disorders
ELECTROLYTE IMBALANCE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Blood and lymphatic system disorders
FACTOR VIII INHIBITION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Blood and lymphatic system disorders
THROMBOTIC THROMBOCYTOPENIC PURPURA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Congenital, familial and genetic disorders
PERICARDIAL EFFUSION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Injury, poisoning and procedural complications
WOUND HAEMORRHAGE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Injury, poisoning and procedural complications
FRACTURE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
3.7%
4/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Vascular disorders
THROMBOSIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Vascular disorders
HYPOVOLAEMIC SHOCK
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Nervous system disorders
CONVULSION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Nervous system disorders
ATAXIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Nervous system disorders
HEMIPARESIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Nervous system disorders
PETIT MAL EPILEPSY
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
SWELLING FACE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Hepatobiliary disorders
GALLBLADDER OBSTRUCTION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Hepatobiliary disorders
JAUNDICE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Eye disorders
OPTIC NERVE DISORDER
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Eye disorders
RETINAL VEIN OCCLUSION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Investigations
LIPASE INCREASED
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CARDIAC NEOPLASM UNSPECIFIED
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
LARGE INTESTINAL OBSTRUCTION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
ESCHERICHIA BACTERAEMIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
UROSEPSIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
Other adverse events
| Measure |
Dose-escalation 10mg b.i.d. Cohort
n=1 participants at risk
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.
|
Dose-escalation 20mg b.i.d. Cohort
n=1 participants at risk
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.
|
Dose-escalation 40mg b.i.d. Cohort
n=1 participants at risk
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
|
Dose-escalation 75mg b.i.d. Cohort
n=1 participants at risk
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.
|
Dose-escalation 150mg b.i.d. Cohort
n=1 participants at risk
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.
|
Dose-escalation 300mg b.i.d. Cohort
n=4 participants at risk
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.
|
Dose-escalation 600mg b.i.d. Cohort
n=7 participants at risk
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.
|
Dose-escalation 750mg b.i.d. Cohort
n=4 participants at risk
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.
|
Dose-escalation 900mg b.i.d. Cohort
n=7 participants at risk
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.
|
Cohort-expansion
n=108 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
42.9%
3/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
19.4%
21/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Cardiac disorders
PALPITATIONS
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
5.6%
6/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
6.5%
7/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Eye disorders
VISUAL IMPAIRMENT
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
9.3%
10/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
28.6%
2/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
11.1%
12/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
28.6%
2/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
42.9%
3/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
23.1%
25/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
DIARRHOEA
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
42.9%
3/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
75.0%
3/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
85.7%
6/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
54.6%
59/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
6.5%
7/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
8.3%
9/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
NAUSEA
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
57.1%
4/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
85.7%
6/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
45.4%
49/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
ORAL PAIN
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
5.6%
6/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
42.9%
3/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
75.0%
3/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
71.4%
5/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
28.7%
31/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
General disorders
ASTHENIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
28.6%
2/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
4.6%
5/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
General disorders
CHILLS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
28.6%
2/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
5.6%
6/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
General disorders
FATIGUE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
50.0%
2/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
71.4%
5/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
7/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
50.0%
54/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
28.6%
2/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
28.6%
2/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.9%
28/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
General disorders
PAIN
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
6.5%
7/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
General disorders
PYREXIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
42.9%
3/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
18.5%
20/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
3.7%
4/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
28.6%
2/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
2.8%
3/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
28.6%
2/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
4.6%
5/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
4.6%
5/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
28.6%
2/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
7.4%
8/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
50.0%
2/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
42.9%
3/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
12.0%
13/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
10.2%
11/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
75.0%
3/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
71.4%
5/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
35.2%
38/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
28.6%
2/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
57.1%
4/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
17.6%
19/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
6.5%
7/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
28.6%
2/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
9.3%
10/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
6.5%
7/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
28.6%
2/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
7.4%
8/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
3.7%
4/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
12.0%
13/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
11.1%
12/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
7.4%
8/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
2.8%
3/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
3.7%
4/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
3.7%
4/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
4.6%
5/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.8%
16/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
11.1%
12/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
42.9%
3/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
9.3%
10/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
28.6%
2/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
42.9%
3/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
9.3%
10/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
75.0%
3/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
28.6%
2/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
18.5%
20/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
3.7%
4/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
28.6%
2/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
6.5%
7/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
10.2%
11/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
42.9%
3/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
50.0%
2/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
42.9%
3/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
33.3%
36/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
16.7%
18/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
42.9%
3/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
28.7%
31/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
42.9%
3/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
50.0%
2/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
28.6%
2/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
24.1%
26/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
42.9%
3/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
10.2%
11/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
4.6%
5/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
7.4%
8/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
8.3%
9/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Renal and urinary disorders
PROTEINURIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
4.6%
5/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
5.6%
6/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
5.6%
6/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
4.6%
5/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
28.6%
2/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
50.0%
2/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
28.7%
31/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
2.8%
3/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
ANAL FISSURE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
CHEILITIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
DIVERTICULUM
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
2.8%
3/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
2.8%
3/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
MELAENA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
PAINFUL DEFAECATION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
PERITONEAL DISORDER
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
ACTINIC KERATOSIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
DECUBITUS ULCER
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
HIRSUTISM
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
MACULE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
NAIL BED DISORDER
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
NAIL GROWTH ABNORMAL
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY REACTION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
3.7%
4/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
General disorders
DISEASE PROGRESSION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
8.3%
9/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
General disorders
APPLICATION SITE RASH
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
General disorders
MALAISE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
General disorders
THIRST
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
3.7%
4/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
2.8%
3/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
3.7%
4/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
2.8%
3/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
2.8%
3/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Respiratory, thoracic and mediastinal disorders
THROAT IRRITATION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
BACTERAEMIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
CANDIDIASIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
FOLLICULITIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
KIDNEY INFECTION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
NAIL INFECTION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
ONYCHOMYCOSIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
PERITONITIS BACTERIAL
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
6.5%
7/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
2.8%
3/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
2.8%
3/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Investigations
BLOOD PHOSPHORUS INCREASED
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Investigations
BODY TEMPERATURE INCREASED
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Investigations
OCCULT BLOOD POSITIVE
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
2.8%
3/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Investigations
PROTEIN TOTAL DECREASED
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Nervous system disorders
ATAXIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Nervous system disorders
CEREBELLAR INFARCTION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Nervous system disorders
TENSION HEADACHE
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
3.7%
4/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE TIGHTNESS
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE TWITCHING
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL DISCOMFORT
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
2.8%
3/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
2.8%
3/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
2.8%
3/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Vascular disorders
HOT FLUSH
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
3.7%
4/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Eye disorders
ABNORMAL SENSATION IN EYE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Eye disorders
BLEPHARITIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Eye disorders
CHALAZION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Eye disorders
CHORIORETINOPATHY
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Eye disorders
EYE DISCHARGE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Eye disorders
MYDRIASIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Eye disorders
PHOTOPHOBIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Injury, poisoning and procedural complications
EXCORIATION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
25.0%
1/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Injury, poisoning and procedural complications
EYE CONTUSION
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Injury, poisoning and procedural complications
INCISION SITE COMPLICATION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Injury, poisoning and procedural complications
LIP INJURY
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Cardiac disorders
CONDUCTION DISORDER
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Psychiatric disorders
AGITATION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
2.8%
3/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
KERATOACANTHOMA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL CANCER
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SEBORRHOEIC KERATOSIS
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
2.8%
3/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Reproductive system and breast disorders
VULVOVAGINAL ERYTHEMA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
1.9%
2/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
14.3%
1/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Surgical and medical procedures
SINUS OPERATION
|
100.0%
1/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.93%
1/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
General disorders
CHEST PAIN
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
5.6%
6/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
4.6%
5/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/1 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/4 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
0.00%
0/7 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
5.6%
6/108 • The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.
A TEAE is any AE temporally assoc. with the use of BVD-523 related or not. If the onset of an AE was missing \& the AE resolution date was either after the initial BVD-523 dose date or missing, then the AE was considered TE. A patient who reported multiple AEs that map to a common PT/SOC was counted only once for that PT/SOC at the highest severity reported \& at the greatest relationship to study drug. AEs were assessed for all participants in Part 2 combined.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place