Trial Outcomes & Findings for A Sequential Two-Stage Dose Escalation Study to Evaluate the Safety and Efficacy of Ruxolitinib (NCT NCT01776723)
NCT ID: NCT01776723
Last Updated: 2022-09-22
Results Overview
Phase I - The MTD is defined as the highest dose where less than 33% of participants experience a drug related predefined dose limited toxicity (DLT). Dose-limiting toxicity (DLT) is defined as any grade 4 hematologic toxicity and any grade 3 or greater non-hematologic toxicity except nausea that is controlled by antiemetic therapy based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3 metabolic/electrolyte abnormalities that are not clinically significant, and are adequately controlled within 72 hours are not to be considered a DLT.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
50 participants
Primary outcome timeframe
17 weeks
Results posted on
2022-09-22
Participant Flow
Participant milestones
| Measure |
Phase 1, Level 1: Ruxolitinib 10 mg
Phase 1, Level 1: Ruxolitinib 5 mg twice daily
|
Phase 1 Level 2: Ruxolitinib 20 mg
Phase 1 Level 2: Ruxolitinib 10 mg twice daily
|
Phase 1 Level 3: Ruxolitinib 30 mg
Phase 1 Level 3: Ruxolitinib 15 mg twice daily
|
Phase 1 Level 4: 40 mg Ruxolitinib
Phase 1 Level 4: 20 mg Ruxolitinib twice daily
|
Phase 2: Maximum Tolerated Dose - Ruxolitinib
Phase II: Treatment at Maximum Tolerated Dose (MTD).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
5
|
5
|
30
|
|
Overall Study
COMPLETED
|
6
|
4
|
5
|
5
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Sequential Two-Stage Dose Escalation Study to Evaluate the Safety and Efficacy of Ruxolitinib
Baseline characteristics by cohort
| Measure |
Phase 1, Level 1: Ruxolitinib 10 mg
n=6 Participants
Phase 1 Level 1: Ruxolitinib 5 mg twice daily
|
Phase 1, Level 2: Ruxolitinib 20 mg
n=4 Participants
Phase 1 Level 2: Ruxolitinib 10 mg twice daily
|
Phase 1, Level 3: Ruxolitinib 30 mg
n=5 Participants
Phase 1 Level 3: Ruxolitinib 15 mg twice daily
|
Phase 1, Level 4: Ruxolitinib 40 mg
n=5 Participants
Phase 1 Level 4: Ruxolitinib 20 mg twice daily
|
Phase 2: Maximum Tolerated Dose - Ruxolitinib
n=30 Participants
Phase 2: Treatment at Maximum Tolerated Dose (MTD).
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
14 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
36 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
19 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
31 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
26 Participants
n=31 Participants
|
44 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
29 Participants
n=31 Participants
|
49 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
4 participants
n=107 Participants
|
5 participants
n=206 Participants
|
5 participants
n=7 Participants
|
30 participants
n=31 Participants
|
50 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 17 weeksPhase I - The MTD is defined as the highest dose where less than 33% of participants experience a drug related predefined dose limited toxicity (DLT). Dose-limiting toxicity (DLT) is defined as any grade 4 hematologic toxicity and any grade 3 or greater non-hematologic toxicity except nausea that is controlled by antiemetic therapy based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3 metabolic/electrolyte abnormalities that are not clinically significant, and are adequately controlled within 72 hours are not to be considered a DLT.
Outcome measures
| Measure |
I: Dose Escalation - Ruxolitinib
n=20 Participants
Phase I: Dose Escalation. In Phase I, participants will be allocated to dose levels starting at 10 mg/d (twice a day \[BID\] dosing) according to the "rolling six" Phase I design.
Ruxolitinib: In Phase I, participants will be allocated to twice a day (BID) doses of 10 mg/d up to 40mg/d. The starting dose will be 10 mg/d (5mg BID). Each cohort will include up to 6 subjects. Once MTD is reached, 10 additional participants will be treated during the first stage of Phase II (stage 1) at the MTD.
|
Phase 1, Level 2: Ruxolitinib 20 mg
Phase 1, Level 2: Ruxolitinib 10 mg twice daily
|
Phase 1, Level 3: Ruxolitinib 30 mg
Phase 1 Level 3: Ruxolitinib 15 mg twice daily
|
Phase 1, Level 4: Ruxolitinib 40 mg
Phase 1, Level 4: Ruxolitinib 20 mg twice daily
|
Maximum Tolerated Dose - Ruxolitinib
Treatment at Maximum Tolerated Dose (MTD).
|
|---|---|---|---|---|---|
|
The Maximum Tolerated Dose (MTD) of Ruxolitinib for the Treatment of Myelomonocytic Leukemia (CMML)
|
40 mg
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All participants who received ruxolitinib therapy
Phase II - Proportion of participants achieving clinical benefit defined as hematologic improvement, complete remission (CR), partial remission (PR), marrow complete remission (Marrow CR) or stable disease (SD) by the International Working Group (IWG) 2006 criteria. Erythroid Response for pretreatment hemoglobin \< 11 g/dl; Platelet response for subjects with a pre-treatment platelet count \< 50 x 10\^9/L; Neutrophil response with pretreatment absolute neutrophil count (ANC) \< 1 x 10\^9/L.
Outcome measures
| Measure |
I: Dose Escalation - Ruxolitinib
n=30 Participants
Phase I: Dose Escalation. In Phase I, participants will be allocated to dose levels starting at 10 mg/d (twice a day \[BID\] dosing) according to the "rolling six" Phase I design.
Ruxolitinib: In Phase I, participants will be allocated to twice a day (BID) doses of 10 mg/d up to 40mg/d. The starting dose will be 10 mg/d (5mg BID). Each cohort will include up to 6 subjects. Once MTD is reached, 10 additional participants will be treated during the first stage of Phase II (stage 1) at the MTD.
|
Phase 1, Level 2: Ruxolitinib 20 mg
Phase 1, Level 2: Ruxolitinib 10 mg twice daily
|
Phase 1, Level 3: Ruxolitinib 30 mg
Phase 1 Level 3: Ruxolitinib 15 mg twice daily
|
Phase 1, Level 4: Ruxolitinib 40 mg
Phase 1, Level 4: Ruxolitinib 20 mg twice daily
|
Maximum Tolerated Dose - Ruxolitinib
Treatment at Maximum Tolerated Dose (MTD).
|
|---|---|---|---|---|---|
|
Occurrence of Clinical Response
|
18 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPhase II - To determine the time to AML transformation of participants on Ruxolitinib. Acute myeloid leukemia (AML) transformation according to World Health Organization (WHO) criteria. CMML-1: peripheral blood \<5% blasts, bone marrow \<10% myeloblast. CMML-2: peripheral blood \<19 percent blasts persistent monocytosis \>1000/ul +/- cytopenias Leukocytosis frequent, bone marrow \<19 percent blasts \>10% dysplasia in affected lineage, Auer Rods.
Outcome measures
| Measure |
I: Dose Escalation - Ruxolitinib
n=30 Participants
Phase I: Dose Escalation. In Phase I, participants will be allocated to dose levels starting at 10 mg/d (twice a day \[BID\] dosing) according to the "rolling six" Phase I design.
Ruxolitinib: In Phase I, participants will be allocated to twice a day (BID) doses of 10 mg/d up to 40mg/d. The starting dose will be 10 mg/d (5mg BID). Each cohort will include up to 6 subjects. Once MTD is reached, 10 additional participants will be treated during the first stage of Phase II (stage 1) at the MTD.
|
Phase 1, Level 2: Ruxolitinib 20 mg
Phase 1, Level 2: Ruxolitinib 10 mg twice daily
|
Phase 1, Level 3: Ruxolitinib 30 mg
Phase 1 Level 3: Ruxolitinib 15 mg twice daily
|
Phase 1, Level 4: Ruxolitinib 40 mg
Phase 1, Level 4: Ruxolitinib 20 mg twice daily
|
Maximum Tolerated Dose - Ruxolitinib
Treatment at Maximum Tolerated Dose (MTD).
|
|---|---|---|---|---|---|
|
Percentage of Participants With Acute Myeloid Leukemia (AML) Transformation
|
14 percentage of patients
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All participants who received ruxolitinib therapy
Phase II - To determine the median overall survival.
Outcome measures
| Measure |
I: Dose Escalation - Ruxolitinib
n=30 Participants
Phase I: Dose Escalation. In Phase I, participants will be allocated to dose levels starting at 10 mg/d (twice a day \[BID\] dosing) according to the "rolling six" Phase I design.
Ruxolitinib: In Phase I, participants will be allocated to twice a day (BID) doses of 10 mg/d up to 40mg/d. The starting dose will be 10 mg/d (5mg BID). Each cohort will include up to 6 subjects. Once MTD is reached, 10 additional participants will be treated during the first stage of Phase II (stage 1) at the MTD.
|
Phase 1, Level 2: Ruxolitinib 20 mg
Phase 1, Level 2: Ruxolitinib 10 mg twice daily
|
Phase 1, Level 3: Ruxolitinib 30 mg
Phase 1 Level 3: Ruxolitinib 15 mg twice daily
|
Phase 1, Level 4: Ruxolitinib 40 mg
Phase 1, Level 4: Ruxolitinib 20 mg twice daily
|
Maximum Tolerated Dose - Ruxolitinib
Treatment at Maximum Tolerated Dose (MTD).
|
|---|---|---|---|---|---|
|
Median Overall Survival (OS)
|
23.7 months
Interval 13.3 to 30.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3.5 yearsPhase II - To determine the duration of response achieved as in secondary endpoint one. The duration of response is measured from the time measurement criteria are met for major or complete platelet response (which ever is first recorded) until the first date that disease progression defined by the bone marrow response outlined above, progression/relapse following a CR, marrow CR or PR, or progressions/relapse following hematological improvement (HI) as outlined above.
Outcome measures
| Measure |
I: Dose Escalation - Ruxolitinib
n=6 Participants
Phase I: Dose Escalation. In Phase I, participants will be allocated to dose levels starting at 10 mg/d (twice a day \[BID\] dosing) according to the "rolling six" Phase I design.
Ruxolitinib: In Phase I, participants will be allocated to twice a day (BID) doses of 10 mg/d up to 40mg/d. The starting dose will be 10 mg/d (5mg BID). Each cohort will include up to 6 subjects. Once MTD is reached, 10 additional participants will be treated during the first stage of Phase II (stage 1) at the MTD.
|
Phase 1, Level 2: Ruxolitinib 20 mg
n=4 Participants
Phase 1, Level 2: Ruxolitinib 10 mg twice daily
|
Phase 1, Level 3: Ruxolitinib 30 mg
n=5 Participants
Phase 1 Level 3: Ruxolitinib 15 mg twice daily
|
Phase 1, Level 4: Ruxolitinib 40 mg
n=5 Participants
Phase 1, Level 4: Ruxolitinib 20 mg twice daily
|
Maximum Tolerated Dose - Ruxolitinib
n=30 Participants
Treatment at Maximum Tolerated Dose (MTD).
|
|---|---|---|---|---|---|
|
Duration of Response in Days
|
104 days
Interval 55.0 to 172.0
|
446.25 days
Interval 28.0 to 961.0
|
718 days
Interval 54.0 to 1248.0
|
331.25 days
Interval 60.0 to 853.0
|
263.5 days
Interval 6.0 to 874.0
|
Adverse Events
Phase 1, Level 1: Ruxolitinib 10 mg
Serious events: 6 serious events
Other events: 6 other events
Deaths: 6 deaths
Phase 1, Level 2: Ruxolitinib 20 mg
Serious events: 4 serious events
Other events: 4 other events
Deaths: 4 deaths
Phase 1, Level 3: Ruxolitinib 30 mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Phase 1, Level 4: Ruxolitinib 40 mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
II: Maximum Tolerated Dose - Ruxolitinib
Serious events: 15 serious events
Other events: 30 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Phase 1, Level 1: Ruxolitinib 10 mg
n=6 participants at risk
Phase 1, Level 1: Ruxolitinib 5 mg twice daily
|
Phase 1, Level 2: Ruxolitinib 20 mg
n=4 participants at risk
Phase 1, Level 1: Ruxolitinib 10 mg twice daily
|
Phase 1, Level 3: Ruxolitinib 30 mg
n=5 participants at risk
Phase 1, Level 1: Ruxolitinib 15 mg twice daily
|
Phase 1, Level 4: Ruxolitinib 40 mg
n=5 participants at risk
Phase 1, Level 1: Ruxolitinib 20 mg twice daily
|
II: Maximum Tolerated Dose - Ruxolitinib
n=30 participants at risk
Phase II: Treatment at Maximum Tolerated Dose (MTD).
|
|---|---|---|---|---|---|
|
Nervous system disorders
Facial muscle weakness
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Investigations
Creatinine increased
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
General disorders
Death NOS
|
100.0%
6/6 • Number of events 6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
100.0%
4/4 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
43.3%
13/30 • Number of events 13 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Nervous system disorders
Nervous system disorders - other
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Blood and lymphatic system disorders
Spleen disorder
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Vascular disorders
Vascular disorders -Other
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Cardiac disorders
Heart failure
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
50.0%
2/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
General disorders
Fatigue
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
50.0%
2/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - other
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Infections and infestations
Infections and infestations - other
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Vascular disorders
Headache
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
General disorders
Multi-organ failure
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Surgical and medical procedures
Surgical and medical procedures -other
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Edema limbs
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - other
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Surgical and medical procedures
Surgical and medical procedures - other
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
General disorders
Flu like symptoms
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
Other adverse events
| Measure |
Phase 1, Level 1: Ruxolitinib 10 mg
n=6 participants at risk
Phase 1, Level 1: Ruxolitinib 5 mg twice daily
|
Phase 1, Level 2: Ruxolitinib 20 mg
n=4 participants at risk
Phase 1, Level 1: Ruxolitinib 10 mg twice daily
|
Phase 1, Level 3: Ruxolitinib 30 mg
n=5 participants at risk
Phase 1, Level 1: Ruxolitinib 15 mg twice daily
|
Phase 1, Level 4: Ruxolitinib 40 mg
n=5 participants at risk
Phase 1, Level 1: Ruxolitinib 20 mg twice daily
|
II: Maximum Tolerated Dose - Ruxolitinib
n=30 participants at risk
Phase II: Treatment at Maximum Tolerated Dose (MTD).
|
|---|---|---|---|---|---|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Infections and infestations
Pleural infection
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Infections and infestations
Laryngitis
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Infections and infestations
Ottis media
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
16.7%
5/30 • Number of events 9 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
23.3%
7/30 • Number of events 8 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
50.0%
2/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
10.0%
3/30 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
13.3%
4/30 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
16.7%
5/30 • Number of events 5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
10.0%
3/30 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
50.0%
2/4 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Hypohidrosis
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Injury, poisoning and procedural complications
Bruising
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
50.0%
2/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
23.3%
7/30 • Number of events 7 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
10.0%
3/30 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
50.0%
2/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
6/30 • Number of events 7 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Psychiatric disorders
Insomnia
|
50.0%
3/6 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
16.7%
5/30 • Number of events 6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Psychiatric disorders
Delirium
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Vascular disorders
Hot flashes
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
16.7%
5/30 • Number of events 5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Vascular disorders
Hematoma
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
10.0%
3/30 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Vascular disorders
Lymphedema
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Cardiac disorders
Atrial fibillation
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
10.0%
3/30 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
2/6 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Cardiac disorders
Heart failure
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
13.3%
4/30 • Number of events 5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
10.0%
3/30 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Renal and urinary disorders
Urinary urgency
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Eye disorders
Cataract
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Eye disorders
Watering eyes
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
13.3%
4/30 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Reproductive system and breast disorders
Testicular disorder
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant or unspecified -Other
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Immune system disorders
Immune system disorders -Other
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders -Other
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
13.3%
4/30 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Eye disorders
Eye disorders -Other
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Renal and urinary disorders
Renal and urinary disorders -Other
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Cardiac disorders
Cardiac disorders - Other
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
50.0%
2/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
10.0%
3/30 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Vascular disorders
Vascular disorders - Other
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Psychiatric disorders
Psychiatric disorders -Other
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedures complications - Other
|
16.7%
1/6 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders -other
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
6/30 • Number of events 7 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder -Other
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
6/30 • Number of events 9 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders -Other
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
75.0%
3/4 • Number of events 7 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Investigations
Investigations - Other
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Nervous system disorders
Nervous system disorders -Other
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - other
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
13.3%
4/30 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - other
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
16.7%
5/30 • Number of events 5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - other
|
16.7%
1/6 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
13.3%
4/30 • Number of events 6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
General disorders
General disorders and administration site conditions - other
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
60.0%
3/5 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
75.0%
3/4 • Number of events 5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
80.0%
4/5 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
33.3%
10/30 • Number of events 11 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
General disorders
Edema limbs
|
50.0%
3/6 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
75.0%
3/4 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
13.3%
4/30 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
General disorders
Fever
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
50.0%
2/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
26.7%
8/30 • Number of events 8 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
13.3%
4/30 • Number of events 6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
General disorders
Chills
|
50.0%
3/6 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
General disorders
Non-cardiac chest pain
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
13.3%
4/30 • Number of events 5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
General disorders
Flu-like symptoms
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
10.0%
3/30 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
General disorders
Edema trunk
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
General disorders
Irritability
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
General disorders
Malaise
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
General disorders
Multi-organ failure
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
75.0%
3/4 • Number of events 11 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
16.7%
5/30 • Number of events 5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
50.0%
2/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
6/30 • Number of events 6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
6/30 • Number of events 8 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Vomitting
|
50.0%
3/6 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
50.0%
2/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
10.0%
3/30 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
13.3%
4/30 • Number of events 5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
16.7%
5/30 • Number of events 6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
2/6 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
10.0%
3/30 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
10.0%
3/30 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Ascites
|
33.3%
2/6 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Esophageal ulcer
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Rectal hemorrhate
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
General disorders
Toothache
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
83.3%
5/6 • Number of events 5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
75.0%
3/4 • Number of events 6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
26.7%
8/30 • Number of events 11 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
50.0%
2/4 • Number of events 8 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
30.0%
9/30 • Number of events 11 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
13.3%
4/30 • Number of events 6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
13.3%
4/30 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
2/6 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
10.0%
3/30 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial stricture
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
50.0%
2/4 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
60.0%
3/5 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
56.7%
17/30 • Number of events 24 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
50.0%
2/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
30.0%
9/30 • Number of events 9 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
30.0%
9/30 • Number of events 15 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
23.3%
7/30 • Number of events 9 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Nervous system disorders
Syncope
|
16.7%
1/6 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
10.0%
3/30 • Number of events 5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Nervous system disorders
Parathesia
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
10.0%
3/30 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Nervous system disorders
Movements involuntary
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
50.0%
2/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Nervous system disorders
Brachial plexopathy
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Nervous system disorders
Dysesthesia
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Nervous system disorders
Facial muscle weakness
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Nervous system disorders
Meningismus
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Nervous system disorders
Spasticity
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
50.0%
2/4 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
36.7%
11/30 • Number of events 17 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
60.0%
3/5 • Number of events 6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
23.3%
7/30 • Number of events 11 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Investigations
Creatinine increased
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
50.0%
2/4 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
16.7%
5/30 • Number of events 8 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
60.0%
3/5 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
10.0%
3/30 • Number of events 5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
13.3%
4/30 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Investigations
Weight gain
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Investigations
White blood cell decreased
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
50.0%
2/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
60.0%
3/5 • Number of events 5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
6/30 • Number of events 9 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
2/6 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
50.0%
2/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
50.0%
2/4 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
10.0%
3/30 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
50.0%
2/4 • Number of events 5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
16.7%
5/30 • Number of events 11 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
10.0%
3/30 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Metabolism and nutrition disorders
Acideosis
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/30 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
50.0%
2/4 • Number of events 7 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
40.0%
2/5 • Number of events 6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
23.3%
7/30 • Number of events 12 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
6/30 • Number of events 10 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
25.0%
1/4 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
3.3%
1/30 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
10.0%
3/30 • Number of events 4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 1 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Infections and infestations
Skin Infection
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
20.0%
1/5 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 3 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
|
Infections and infestations
Bladder infection
|
0.00%
0/6 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/4 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
0.00%
0/5 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
6.7%
2/30 • Number of events 2 • Adverse Events collected from time of consent through follow-up, up to 2 years
|
Additional Information
Eric Padron, MD
H Lee Moffitt Cancer Center & Research Institute
Phone: 813-745-3907
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place