Trial Outcomes & Findings for SLM + Axitinib for Clear Cell RCC (NCT NCT02535533)
NCT ID: NCT02535533
Last Updated: 2026-05-06
Results Overview
The AEs will be summarized and classified by body system and by treatment group. The type, incidence, severity, and causality of each AE, the duration of the event, and any required treatment interventions will be tabulated.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
45 participants
Primary outcome timeframe
After 2 cycles (28 days)
Results posted on
2026-05-06
Participant Flow
Participant milestones
| Measure |
Pilot Cohort-Dose Level 3 (BSA-adjusted)
A pilot group will have SLM dose calculated based on patients' Body Surface Area (BSA) to characterize the dose-concentration relationship and estimate the effective administered dose of selenium necessary to achieve the target blood concentration range informed by preclinical data.
Participants receive selenium at Dose Level 3, adjusted for body surface area (BSA):
* BSA 1.50-1.79 m² → 4000 mcg BID
* BSA 1.80-2.19 m² → 5000 mcg BID
* BSA 2.20-2.49 m² → 6000 mcg BID
Administered BID on Days 1-14, then daily until progression.
|
Dose Escalation Phase 1: SLM 2500mcg / Axitinib 5mg
SLM administrated orally twice daily for 14 days, followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Dose Escalation Phase 1: SLM 3000mcg / Axitinib 5mg
SLM administrated orally twice daily for 14 days, followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Dose Escalation Phase 1: SLM 4000mcg / Axitinib 5mg
SLM administrated orally twice daily for 14 days, followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Dose Expansion Phase 2: SLM 4000mcg / Axitinib 5mg
In this expansion phase, participants will be treated at the maximum tolerated dose (MTD) of SLM determined in the Escalation Phase 1. It will be given orally twice daily for 14 days, followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Pilot Cohort-Level 4 Dose (BSA-adjusted)
A pilot group will have SLM dose calculated based on patients' Body Surface Area (BSA) to characterize the dose-concentration relationship and estimate the effective administered dose of selenium necessary to achieve the target blood concentration range informed by preclinical data.
Participants receive selenium at Dose Level 4, adjusted for body surface area (BSA):
* BSA 1.50-1.79 m² → 5000 mcg BID
* BSA 1.80-2.19 m² → 6000 mcg BID
* BSA 2.20-2.49 m² → 7000 mcg BID
Administered BID on Days 1-14, then daily until progression.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
3
|
5
|
7
|
20
|
2
|
|
Overall Study
COMPLETED
|
2
|
0
|
0
|
2
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
5
|
5
|
16
|
0
|
Reasons for withdrawal
| Measure |
Pilot Cohort-Dose Level 3 (BSA-adjusted)
A pilot group will have SLM dose calculated based on patients' Body Surface Area (BSA) to characterize the dose-concentration relationship and estimate the effective administered dose of selenium necessary to achieve the target blood concentration range informed by preclinical data.
Participants receive selenium at Dose Level 3, adjusted for body surface area (BSA):
* BSA 1.50-1.79 m² → 4000 mcg BID
* BSA 1.80-2.19 m² → 5000 mcg BID
* BSA 2.20-2.49 m² → 6000 mcg BID
Administered BID on Days 1-14, then daily until progression.
|
Dose Escalation Phase 1: SLM 2500mcg / Axitinib 5mg
SLM administrated orally twice daily for 14 days, followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Dose Escalation Phase 1: SLM 3000mcg / Axitinib 5mg
SLM administrated orally twice daily for 14 days, followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Dose Escalation Phase 1: SLM 4000mcg / Axitinib 5mg
SLM administrated orally twice daily for 14 days, followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Dose Expansion Phase 2: SLM 4000mcg / Axitinib 5mg
In this expansion phase, participants will be treated at the maximum tolerated dose (MTD) of SLM determined in the Escalation Phase 1. It will be given orally twice daily for 14 days, followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Pilot Cohort-Level 4 Dose (BSA-adjusted)
A pilot group will have SLM dose calculated based on patients' Body Surface Area (BSA) to characterize the dose-concentration relationship and estimate the effective administered dose of selenium necessary to achieve the target blood concentration range informed by preclinical data.
Participants receive selenium at Dose Level 4, adjusted for body surface area (BSA):
* BSA 1.50-1.79 m² → 5000 mcg BID
* BSA 1.80-2.19 m² → 6000 mcg BID
* BSA 2.20-2.49 m² → 7000 mcg BID
Administered BID on Days 1-14, then daily until progression.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
0
|
3
|
0
|
|
Overall Study
Alternative therapy
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Disease progression
|
4
|
2
|
3
|
5
|
11
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Other complicating disease
|
0
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
SLM + Axitinib for Clear Cell RCC
Baseline characteristics by cohort
| Measure |
Dose Escalation Phase 1: SLM 2500mcg / Axitinib 5mg
n=3 Participants
SLM administrated orally twice daily for 14 days, followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Dose Escalation Phase 1: SLM 3000mcg / Axitinib 5mg
n=5 Participants
SLM administrated orally twice daily for 14 days, followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Dose Escalation Phase 1: SLM 4000mcg / Axitinib 5mg
n=7 Participants
SLM administrated orally twice daily for 14 days, followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Dose Expansion Phase 2: SLM 4000mcg / Axitinib 5mg
n=20 Participants
In this expansion phase, participants will be treated at the maximum tolerated dose (MTD) of SLM determined in the Escalation Phase 1. It will be given orally twice daily for 14 days, followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Pilot Cohort-Dose Level 3 (BSA-adjusted)
n=8 Participants
A pilot group will have SLM dose calculated based on patients' Body Surface Area (BSA) to characterize the dose-concentration relationship and estimate the effective administered dose of selenium necessary to achieve the target blood concentration range informed by preclinical data.
Participants receive selenium at Dose Level 3, adjusted for body surface area (BSA):
BSA 1.50-1.79 m² → 4000 mcg BID BSA 1.80-2.19 m² → 5000 mcg BID BSA 2.20-2.49 m² → 6000 mcg BID Administered BID on Days 1-14, then daily until progression.
|
Pilot Cohort-Level 4 Dose (BSA-adjusted)
n=2 Participants
A pilot group will have SLM dose calculated based on patients' Body Surface Area (BSA) to characterize the dose-concentration relationship and estimate the effective administered dose of selenium necessary to achieve the target blood concentration range informed by preclinical data.
Participants receive selenium at Dose Level 4, adjusted for body surface area (BSA):
BSA 1.50-1.79 m² → 5000 mcg BID BSA 1.80-2.19 m² → 6000 mcg BID BSA 2.20-2.49 m² → 7000 mcg BID Administered BID on Days 1-14, then daily until progression.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
3 Participants
n=480 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=19 Participants
|
10 Participants
n=88 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=54 Participants
|
4 Participants
n=60 Participants
|
6 Participants
n=114 Participants
|
17 Participants
n=480 Participants
|
5 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
35 Participants
n=88 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=88 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
5 Participants
n=114 Participants
|
12 Participants
n=480 Participants
|
6 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
29 Participants
n=88 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
8 Participants
n=480 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=19 Participants
|
16 Participants
n=88 Participants
|
|
Age, Continuous
|
55 years
n=54 Participants
|
64 years
n=60 Participants
|
59 years
n=114 Participants
|
62 years
n=480 Participants
|
58 years
n=24 Participants
|
69 years
n=19 Participants
|
61 years
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=54 Participants
|
5 Participants
n=60 Participants
|
7 Participants
n=114 Participants
|
19 Participants
n=480 Participants
|
8 Participants
n=24 Participants
|
2 Participants
n=19 Participants
|
44 Participants
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=480 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=88 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=54 Participants
|
5 Participants
n=60 Participants
|
7 Participants
n=114 Participants
|
19 Participants
n=480 Participants
|
8 Participants
n=24 Participants
|
2 Participants
n=19 Participants
|
44 Participants
n=88 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=480 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=88 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=54 Participants
|
5 participants
n=60 Participants
|
7 participants
n=114 Participants
|
20 participants
n=480 Participants
|
8 participants
n=24 Participants
|
2 participants
n=19 Participants
|
45 participants
n=88 Participants
|
PRIMARY outcome
Timeframe: After 2 cycles (28 days)Population: Number of participants who received study drug and assessed for adverse events
The AEs will be summarized and classified by body system and by treatment group. The type, incidence, severity, and causality of each AE, the duration of the event, and any required treatment interventions will be tabulated.
Outcome measures
| Measure |
Dose-Escalation Phase I: SLM 2500mcg / Axitnib 5mg
n=3 Participants
SLM will be given twice daily for 14 days followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma. Treatment will continue until disease progression or unacceptable toxicity.
|
Dose-Escalation Phase I: SLM 3000mcg / Axitnib 5mg
n=5 Participants
SLM will be given twice daily for 14 days followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma. Treatment will continue until disease progression or unacceptable toxicity.
|
Dose-Escalation Phase I: SLM 4000mcg / Axitnib 5mg
n=7 Participants
SLM will be given twice daily for 14 days followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma. Treatment will continue until disease progression or unacceptable toxicity.
|
Dose Expansion Phase 2: SLM 4000mcg / Axitnib 5mg
n=20 Participants
In this phase, participants will be treated at the maximum tolerated dose (MTD) of SLM determined in the Escalation Part 1. It will be given orally twice daily for 14 days, followed by once daily dosing in combination with axitinib 5 mg twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Pilot Cohort-Dose Level 3 (BSA-adjusted)
n=8 Participants
A pilot group will have SLM dose calculated based on patients' Body Surface Area (BSA) to characterize the dose-concentration relationship and estimate the effective administered dose of selenium necessary to achieve the target blood concentration range informed by preclinical data.
Participants receive selenium at Dose Level 3, adjusted for body surface area (BSA):
* BSA 1.50-1.79 m² → 4000 mcg BID
* BSA 1.80-2.19 m² → 5000 mcg BID
* BSA 2.20-2.49 m² → 6000 mcg BID
Administered BID on Days 1-14, then daily until progression.
|
Pilot Cohort-Dose Level 4 (BSA-adjusted)
n=2 Participants
A pilot group will have SLM dose calculated based on patients' Body Surface Area (BSA) to characterize the dose-concentration relationship and estimate the effective administered dose of selenium necessary to achieve the target blood concentration range informed by preclinical data.
Participants receive selenium at Dose Level 4, adjusted for body surface area (BSA):
* BSA 1.50-1.79 m² → 5000 mcg BID
* BSA 1.80-2.19 m² → 6000 mcg BID
* BSA 2.20-2.49 m² → 7000 mcg BID
Administered BID on Days 1-14, then daily until progression.
|
|---|---|---|---|---|---|---|
|
Incidence of Adverse Events (AE) Per CTCAE 4.03
|
3 Participants
|
5 Participants
|
7 Participants
|
20 Participants
|
8 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Although participants were enrolled and dosing occurred in the pilot phase, the pre-specified analysis of the dose-concentration relationship using the CRM could not be performed. The pre-specified sample size needed to estimate the dose-concentration relationship and determine the effective dose was not reached due to lack of funding. Therefore, estimates of the dose-concentration curve and effective dose of SLM are not and will not be available to report in the future.
Dose escalation for this pilot study will be conducted using a CRM in which the probability of exceeding a blood selenium concentration of 45 µM on Day 14 is being modeled. Prior probabilities of exceeding a blood selenium concentration of 45 µM on Day 14 were estimated based on preclinical and preliminary data from the initial trial. A one parameter logistic model with intercept set at 3 and an initial value of 1 for the slope will be used to estimate the dose-concentration relationship through sequential recursive Bayesian assessment. The target probability of exceeding 45 µM is ≤20%.
Outcome measures
| Measure |
Dose-Escalation Phase I: SLM 2500mcg / Axitnib 5mg
SLM will be given twice daily for 14 days followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma. Treatment will continue until disease progression or unacceptable toxicity.
|
Dose-Escalation Phase I: SLM 3000mcg / Axitnib 5mg
SLM will be given twice daily for 14 days followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma. Treatment will continue until disease progression or unacceptable toxicity.
|
Dose-Escalation Phase I: SLM 4000mcg / Axitnib 5mg
SLM will be given twice daily for 14 days followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma. Treatment will continue until disease progression or unacceptable toxicity.
|
Dose Expansion Phase 2: SLM 4000mcg / Axitnib 5mg
In this phase, participants will be treated at the maximum tolerated dose (MTD) of SLM determined in the Escalation Part 1. It will be given orally twice daily for 14 days, followed by once daily dosing in combination with axitinib 5 mg twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Pilot Cohort-Dose Level 3 (BSA-adjusted)
A pilot group will have SLM dose calculated based on patients' Body Surface Area (BSA) to characterize the dose-concentration relationship and estimate the effective administered dose of selenium necessary to achieve the target blood concentration range informed by preclinical data.
Participants receive selenium at Dose Level 3, adjusted for body surface area (BSA):
* BSA 1.50-1.79 m² → 4000 mcg BID
* BSA 1.80-2.19 m² → 5000 mcg BID
* BSA 2.20-2.49 m² → 6000 mcg BID
Administered BID on Days 1-14, then daily until progression.
|
Pilot Cohort-Dose Level 4 (BSA-adjusted)
A pilot group will have SLM dose calculated based on patients' Body Surface Area (BSA) to characterize the dose-concentration relationship and estimate the effective administered dose of selenium necessary to achieve the target blood concentration range informed by preclinical data.
Participants receive selenium at Dose Level 4, adjusted for body surface area (BSA):
* BSA 1.50-1.79 m² → 5000 mcg BID
* BSA 1.80-2.19 m² → 6000 mcg BID
* BSA 2.20-2.49 m² → 7000 mcg BID
Administered BID on Days 1-14, then daily until progression.
|
|---|---|---|---|---|---|---|
|
Pilot Phase - Determine Dose-concentration Relationship and Estimate the Effective Dose of SLM (Informed by Preclinical Data) Using the Continual Reassessment Method (CRM).
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From treatment initiation to treatment end, up to 3 yearsPopulation: Efficacy endpoints (e.g. ORR) were pre-specified only for participants treated at the MTD of SLM in the Dose-Escalation and Dose Expansion parts.
The overall response rate is the percentage of patients with a confirmed complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Dose-Escalation Phase I: SLM 2500mcg / Axitnib 5mg
n=27 Participants
SLM will be given twice daily for 14 days followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma. Treatment will continue until disease progression or unacceptable toxicity.
|
Dose-Escalation Phase I: SLM 3000mcg / Axitnib 5mg
SLM will be given twice daily for 14 days followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma. Treatment will continue until disease progression or unacceptable toxicity.
|
Dose-Escalation Phase I: SLM 4000mcg / Axitnib 5mg
SLM will be given twice daily for 14 days followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma. Treatment will continue until disease progression or unacceptable toxicity.
|
Dose Expansion Phase 2: SLM 4000mcg / Axitnib 5mg
In this phase, participants will be treated at the maximum tolerated dose (MTD) of SLM determined in the Escalation Part 1. It will be given orally twice daily for 14 days, followed by once daily dosing in combination with axitinib 5 mg twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Pilot Cohort-Dose Level 3 (BSA-adjusted)
A pilot group will have SLM dose calculated based on patients' Body Surface Area (BSA) to characterize the dose-concentration relationship and estimate the effective administered dose of selenium necessary to achieve the target blood concentration range informed by preclinical data.
Participants receive selenium at Dose Level 3, adjusted for body surface area (BSA):
* BSA 1.50-1.79 m² → 4000 mcg BID
* BSA 1.80-2.19 m² → 5000 mcg BID
* BSA 2.20-2.49 m² → 6000 mcg BID
Administered BID on Days 1-14, then daily until progression.
|
Pilot Cohort-Dose Level 4 (BSA-adjusted)
A pilot group will have SLM dose calculated based on patients' Body Surface Area (BSA) to characterize the dose-concentration relationship and estimate the effective administered dose of selenium necessary to achieve the target blood concentration range informed by preclinical data.
Participants receive selenium at Dose Level 4, adjusted for body surface area (BSA):
* BSA 1.50-1.79 m² → 5000 mcg BID
* BSA 1.80-2.19 m² → 6000 mcg BID
* BSA 2.20-2.49 m² → 7000 mcg BID
Administered BID on Days 1-14, then daily until progression.
|
|---|---|---|---|---|---|---|
|
Overall Response Rate
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From treatment initiation up to 2 yearsPopulation: Efficacy endpoints (e.g. PFS) were pre-specified only for participants treated at the MTD of SLM in the Dose-Escalation and Dose Expansion parts.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Dose-Escalation Phase I: SLM 2500mcg / Axitnib 5mg
n=27 Participants
SLM will be given twice daily for 14 days followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma. Treatment will continue until disease progression or unacceptable toxicity.
|
Dose-Escalation Phase I: SLM 3000mcg / Axitnib 5mg
SLM will be given twice daily for 14 days followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma. Treatment will continue until disease progression or unacceptable toxicity.
|
Dose-Escalation Phase I: SLM 4000mcg / Axitnib 5mg
SLM will be given twice daily for 14 days followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma. Treatment will continue until disease progression or unacceptable toxicity.
|
Dose Expansion Phase 2: SLM 4000mcg / Axitnib 5mg
In this phase, participants will be treated at the maximum tolerated dose (MTD) of SLM determined in the Escalation Part 1. It will be given orally twice daily for 14 days, followed by once daily dosing in combination with axitinib 5 mg twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Pilot Cohort-Dose Level 3 (BSA-adjusted)
A pilot group will have SLM dose calculated based on patients' Body Surface Area (BSA) to characterize the dose-concentration relationship and estimate the effective administered dose of selenium necessary to achieve the target blood concentration range informed by preclinical data.
Participants receive selenium at Dose Level 3, adjusted for body surface area (BSA):
* BSA 1.50-1.79 m² → 4000 mcg BID
* BSA 1.80-2.19 m² → 5000 mcg BID
* BSA 2.20-2.49 m² → 6000 mcg BID
Administered BID on Days 1-14, then daily until progression.
|
Pilot Cohort-Dose Level 4 (BSA-adjusted)
A pilot group will have SLM dose calculated based on patients' Body Surface Area (BSA) to characterize the dose-concentration relationship and estimate the effective administered dose of selenium necessary to achieve the target blood concentration range informed by preclinical data.
Participants receive selenium at Dose Level 4, adjusted for body surface area (BSA):
* BSA 1.50-1.79 m² → 5000 mcg BID
* BSA 1.80-2.19 m² → 6000 mcg BID
* BSA 2.20-2.49 m² → 7000 mcg BID
Administered BID on Days 1-14, then daily until progression.
|
|---|---|---|---|---|---|---|
|
Progression-Free Survival
|
14.8 months
Interval 6.0 to 20.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From treatment initiation up to 3 yearsPopulation: Efficacy endpoints (e.g. OS) were pre-specified only for participants treated at the MTD of SLM in the Dose-Escalation and Dose Expansion parts.
Overall survival is defined as the time from study treatment initiation to death due to any cause. Patients still alive were censored at the last date known to be alive.
Outcome measures
| Measure |
Dose-Escalation Phase I: SLM 2500mcg / Axitnib 5mg
n=27 Participants
SLM will be given twice daily for 14 days followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma. Treatment will continue until disease progression or unacceptable toxicity.
|
Dose-Escalation Phase I: SLM 3000mcg / Axitnib 5mg
SLM will be given twice daily for 14 days followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma. Treatment will continue until disease progression or unacceptable toxicity.
|
Dose-Escalation Phase I: SLM 4000mcg / Axitnib 5mg
SLM will be given twice daily for 14 days followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma. Treatment will continue until disease progression or unacceptable toxicity.
|
Dose Expansion Phase 2: SLM 4000mcg / Axitnib 5mg
In this phase, participants will be treated at the maximum tolerated dose (MTD) of SLM determined in the Escalation Part 1. It will be given orally twice daily for 14 days, followed by once daily dosing in combination with axitinib 5 mg twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Pilot Cohort-Dose Level 3 (BSA-adjusted)
A pilot group will have SLM dose calculated based on patients' Body Surface Area (BSA) to characterize the dose-concentration relationship and estimate the effective administered dose of selenium necessary to achieve the target blood concentration range informed by preclinical data.
Participants receive selenium at Dose Level 3, adjusted for body surface area (BSA):
* BSA 1.50-1.79 m² → 4000 mcg BID
* BSA 1.80-2.19 m² → 5000 mcg BID
* BSA 2.20-2.49 m² → 6000 mcg BID
Administered BID on Days 1-14, then daily until progression.
|
Pilot Cohort-Dose Level 4 (BSA-adjusted)
A pilot group will have SLM dose calculated based on patients' Body Surface Area (BSA) to characterize the dose-concentration relationship and estimate the effective administered dose of selenium necessary to achieve the target blood concentration range informed by preclinical data.
Participants receive selenium at Dose Level 4, adjusted for body surface area (BSA):
* BSA 1.50-1.79 m² → 5000 mcg BID
* BSA 1.80-2.19 m² → 6000 mcg BID
* BSA 2.20-2.49 m² → 7000 mcg BID
Administered BID on Days 1-14, then daily until progression.
|
|---|---|---|---|---|---|---|
|
Overall Survival
|
19.6 months
Interval 12.0 to 40.6
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Period 1: Phase 1: SLM 2500
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Period 2: Phase 1: SLM 3000
Serious events: 4 serious events
Other events: 5 other events
Deaths: 3 deaths
Period 3: Phase 1: SLM 4000
Serious events: 7 serious events
Other events: 7 other events
Deaths: 5 deaths
Period 4: Phase 2: SLM 4000
Serious events: 5 serious events
Other events: 20 other events
Deaths: 16 deaths
Period 5: Pilot: SLM Dose Level 3
Serious events: 4 serious events
Other events: 8 other events
Deaths: 5 deaths
Period 6: Pilot: SLM Dose Level 4
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Period 1: Phase 1: SLM 2500
n=3 participants at risk
SLM administrated orally twice daily for 14 days, followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Period 2: Phase 1: SLM 3000
n=5 participants at risk
SLM administrated orally twice daily for 14 days, followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Period 3: Phase 1: SLM 4000
n=7 participants at risk
SLM administrated orally twice daily for 14 days, followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Period 4: Phase 2: SLM 4000
n=20 participants at risk
In this expansion phase, participants will be treated at the maximum tolerated dose (MTD) of SLM determined in the Escalation Phase 1. It will be given orally twice daily for 14 days, followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Period 5: Pilot: SLM Dose Level 3
n=8 participants at risk
A pilot group will have SLM dose calculated based on patients' Body Surface Area (BSA) to characterize the dose-concentration relationship and estimate the effective administered dose of selenium necessary to achieve the target blood concentration range informed by preclinical data.
Participants receive selenium at Dose Level 3, adjusted for body surface area (BSA):
BSA 1.50-1.79 m² → 4000 mcg BID BSA 1.80-2.19 m² → 5000 mcg BID BSA 2.20-2.49 m² → 6000 mcg BID
Administered BID on Days 1-14, then daily until progression.
|
Period 6: Pilot: SLM Dose Level 4
n=2 participants at risk
A pilot group will have SLM dose calculated based on patients' Body Surface Area (BSA) to characterize the dose-concentration relationship and estimate the effective administered dose of selenium necessary to achieve the target blood concentration range informed by preclinical data.
Participants receive selenium at Dose Level 4, adjusted for body surface area (BSA):
BSA 1.50-1.79 m² → 5000 mcg BID BSA 1.80-2.19 m² → 6000 mcg BID BSA 2.20-2.49 m² → 7000 mcg BID
Administered BID on Days 1-14, then daily until progression.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
2/8 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
General disorders and administration site conditions
Fatigue
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
General disorders and administration site conditions
Fever
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
General disorders and administration site conditions
Flu like symptoms
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
General disorders and administration site conditions
Pain
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
10.0%
2/20 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
33.3%
1/3 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
Other adverse events
| Measure |
Period 1: Phase 1: SLM 2500
n=3 participants at risk
SLM administrated orally twice daily for 14 days, followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Period 2: Phase 1: SLM 3000
n=5 participants at risk
SLM administrated orally twice daily for 14 days, followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Period 3: Phase 1: SLM 4000
n=7 participants at risk
SLM administrated orally twice daily for 14 days, followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Period 4: Phase 2: SLM 4000
n=20 participants at risk
In this expansion phase, participants will be treated at the maximum tolerated dose (MTD) of SLM determined in the Escalation Phase 1. It will be given orally twice daily for 14 days, followed by once daily dosing in combination with axitinib twice daily with titration according to package insert in patients with advanced renal cell carcinoma.
|
Period 5: Pilot: SLM Dose Level 3
n=8 participants at risk
A pilot group will have SLM dose calculated based on patients' Body Surface Area (BSA) to characterize the dose-concentration relationship and estimate the effective administered dose of selenium necessary to achieve the target blood concentration range informed by preclinical data.
Participants receive selenium at Dose Level 3, adjusted for body surface area (BSA):
BSA 1.50-1.79 m² → 4000 mcg BID BSA 1.80-2.19 m² → 5000 mcg BID BSA 2.20-2.49 m² → 6000 mcg BID
Administered BID on Days 1-14, then daily until progression.
|
Period 6: Pilot: SLM Dose Level 4
n=2 participants at risk
A pilot group will have SLM dose calculated based on patients' Body Surface Area (BSA) to characterize the dose-concentration relationship and estimate the effective administered dose of selenium necessary to achieve the target blood concentration range informed by preclinical data.
Participants receive selenium at Dose Level 4, adjusted for body surface area (BSA):
BSA 1.50-1.79 m² → 5000 mcg BID BSA 1.80-2.19 m² → 6000 mcg BID BSA 2.20-2.49 m² → 7000 mcg BID
Administered BID on Days 1-14, then daily until progression.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
33.3%
1/3 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
10.0%
2/20 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
42.9%
3/7 • Number of events 8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
4/20 • Number of events 11 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
4/8 • Number of events 9 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
66.7%
2/3 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
42.9%
3/7 • Number of events 7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
10.0%
2/20 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
2/8 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
10.0%
2/20 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
42.9%
3/7 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
30.0%
6/20 • Number of events 9 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
2/8 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Bloating
|
33.3%
1/3 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
10.0%
2/20 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
35.0%
7/20 • Number of events 11 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
60.0%
3/5 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
71.4%
5/7 • Number of events 25 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
75.0%
15/20 • Number of events 36 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
4/8 • Number of events 13 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
10.0%
2/20 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
10.0%
2/20 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
2/8 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
57.1%
4/7 • Number of events 6 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
30.0%
6/20 • Number of events 10 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
42.9%
3/7 • Number of events 5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
5/20 • Number of events 6 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
37.5%
3/8 • Number of events 7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
40.0%
2/5 • Number of events 5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
85.7%
6/7 • Number of events 14 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
10/20 • Number of events 12 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
62.5%
5/8 • Number of events 6 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
100.0%
2/2 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
15.0%
3/20 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Pancreatic necrosis
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Stomach pain
|
33.3%
1/3 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
71.4%
5/7 • Number of events 11 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
5/20 • Number of events 9 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
4/8 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
1/2 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
General disorders and administration site conditions
Chills
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
57.1%
4/7 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
General disorders and administration site conditions
Edema face
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
General disorders and administration site conditions
Edema limbs
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
10.0%
2/20 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
General disorders and administration site conditions
Fatigue
|
100.0%
3/3 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
60.0%
3/5 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
85.7%
6/7 • Number of events 18 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
85.0%
17/20 • Number of events 47 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
75.0%
6/8 • Number of events 17 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
100.0%
2/2 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
General disorders and administration site conditions
Fever
|
33.3%
1/3 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
57.1%
4/7 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
General disorders and administration site conditions
Flu like symptoms
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
General disorders and administration site conditions
Gait disturbance
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
General disorders and administration site conditions
General disorders and administration site conditions - Other, specify
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
40.0%
2/5 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
57.1%
4/7 • Number of events 8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
100.0%
2/2 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
General disorders and administration site conditions
Hypothermia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
General disorders and administration site conditions
Infusion site extravasation
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
General disorders and administration site conditions
Irritability
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
General disorders and administration site conditions
Malaise
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
General disorders and administration site conditions
Pain
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
10.0%
2/20 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
2/8 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
42.9%
3/7 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
5/20 • Number of events 7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Infections and infestations
Laryngitis
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
10.0%
2/20 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Infections and infestations
Otitis media
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Infections and infestations
Sinusitis
|
33.3%
1/3 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
1/3 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
10.0%
2/20 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
2/8 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
57.1%
4/7 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
10.0%
2/20 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
2/8 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 10 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
4/20 • Number of events 10 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
1/2 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
42.9%
3/7 • Number of events 5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
15.0%
3/20 • Number of events 5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
42.9%
3/7 • Number of events 18 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
40.0%
8/20 • Number of events 18 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
37.5%
3/8 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Investigations
Hemoglobin increased
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
5/20 • Number of events 7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Investigations
INR increased
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Investigations
Investigations - Other, specify
|
66.7%
2/3 • Number of events 5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
71.4%
5/7 • Number of events 72 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
10.0%
2/20 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Investigations
Lipase increased
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Investigations
Lymphocyte count decreased
|
66.7%
2/3 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
2/8 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Investigations
Serum amylase increased
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Investigations
Weight loss
|
33.3%
1/3 • Number of events 8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
40.0%
2/5 • Number of events 5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
57.1%
4/7 • Number of events 26 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
65.0%
13/20 • Number of events 46 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
4/8 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
1/2 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
60.0%
3/5 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
71.4%
5/7 • Number of events 17 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
10/20 • Number of events 24 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
87.5%
7/8 • Number of events 10 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
71.4%
5/7 • Number of events 12 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
15.0%
3/20 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
33.3%
1/3 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
10.0%
2/20 • Number of events 9 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
2/8 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 6 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
42.9%
3/7 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
4/20 • Number of events 12 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
1/3 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
10.0%
2/20 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
2/8 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
42.9%
3/7 • Number of events 8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
66.7%
2/3 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
35.0%
7/20 • Number of events 9 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
37.5%
3/8 • Number of events 5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
4/20 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
42.9%
3/7 • Number of events 6 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
30.0%
6/20 • Number of events 7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
60.0%
3/5 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
10.0%
2/20 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
35.0%
7/20 • Number of events 13 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
1/2 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
33.3%
1/3 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
71.4%
5/7 • Number of events 8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
40.0%
8/20 • Number of events 15 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
15.0%
3/20 • Number of events 5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
40.0%
2/5 • Number of events 5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
42.9%
3/7 • Number of events 9 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
4/20 • Number of events 5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
2/8 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
42.9%
3/7 • Number of events 5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Dysgeusia
|
66.7%
2/3 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
5/20 • Number of events 5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
80.0%
4/5 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
15.0%
3/20 • Number of events 6 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
2/8 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
10.0%
2/20 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
40.0%
2/5 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
15.0%
3/20 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
4/20 • Number of events 6 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
37.5%
3/8 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Renal and urinary disorders
Hematuria
|
33.3%
1/3 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
15.0%
3/20 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
2/8 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
1/3 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
57.1%
4/7 • Number of events 30 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
5/20 • Number of events 20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
1/2 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
57.1%
4/7 • Number of events 9 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
15.0%
3/20 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
10.0%
2/20 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
33.3%
1/3 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
33.3%
1/3 • Number of events 5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
40.0%
2/5 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
71.4%
5/7 • Number of events 13 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
5/20 • Number of events 6 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
37.5%
3/8 • Number of events 5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
60.0%
3/5 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
71.4%
5/7 • Number of events 8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
40.0%
8/20 • Number of events 18 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
2/8 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
10.0%
2/20 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
42.9%
3/7 • Number of events 9 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
60.0%
12/20 • Number of events 17 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
4/8 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
33.3%
1/3 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
2/8 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
10.0%
2/20 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
66.7%
2/3 • Number of events 8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
57.1%
4/7 • Number of events 7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
10.0%
2/20 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
2/8 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
33.3%
1/3 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
33.3%
1/3 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
4/20 • Number of events 7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
33.3%
1/3 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
10.0%
2/20 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
40.0%
8/20 • Number of events 25 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
2/8 • Number of events 7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
100.0%
2/2 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
4/20 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
100.0%
2/2 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
28.6%
2/7 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
5/20 • Number of events 7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 4 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
42.9%
3/7 • Number of events 6 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
30.0%
6/20 • Number of events 10 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/20 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Vascular disorders
Hematoma
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Vascular disorders
Hot flashes
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
40.0%
2/5 • Number of events 5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
85.7%
6/7 • Number of events 15 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
45.0%
9/20 • Number of events 26 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
62.5%
5/8 • Number of events 7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
50.0%
1/2 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
14.3%
1/7 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
25.0%
5/20 • Number of events 9 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
20.0%
1/5 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
15.0%
3/20 • Number of events 3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
12.5%
1/8 • Number of events 1 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/3 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/5 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/7 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
5.0%
1/20 • Number of events 2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/8 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
0.00%
0/2 • All adverse events (regardless of grade and attribution) observed from initiation of treatment and for up to 30 days after last dose of study drug, up to 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place