Trial Outcomes & Findings for A Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated CXCR4 Waldenstrom's Macroglobulinemia (NCT NCT03225716)
NCT ID: NCT03225716
Last Updated: 2024-05-03
Results Overview
MTD was determined by testing increasing doses up to 1600mg of ulocuplumab on dose escalation levels 1 to 3 with 3 to 7 participants each. MTD reflects the highest dose of ulocuplumab that did not cause a Dose-Limiting Toxicity (DLT) in \>33% of participants. DLTs were defined as any Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0) grade 4 or 5 hematologic toxicities (anemia, neutropenia, or thrombocytopenia) and grade 3 or above non-hematologic toxicities. Exceptions were allowed for toxicities attributed to underlying disease, grade 3 infection, and easily reversible asymptomatic laboratory abnormalities, and nausea, vomiting, or diarrhea controlled by medications.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
Up to 8 weeks for each dose level
Results posted on
2024-05-03
Participant Flow
Participant milestones
| Measure |
Phase 1 Dose Level 1: Ibrutinib + Ulocuplumab 400mg Cycle 1 and 800mg Cycles 2-6
* Ibrutinib administered orally once daily for 48 cycles
* Ulocuplumab administered intravenously at 400mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 800mg for Cycles 2-6 on Days 1 and 15.
Ulocuplumab: Ulocuplumab is a type of protein called an antibody that attacks CXCR4
Ibrutinib: Ibrutinib small-molecule inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity
|
Phase 1 Dose Level 2: Ibrutinib + Ulocuplumab 800 mg Cycle 1 and 1200mg Cycles 2-6
* Ibrutinib administered orally once daily for 48 cycles
* Ulocuplumab administered intravenously at 800mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 1200mg for Cycles 2-6 on Days 1 and 15.
Ulocuplumab: Ulocuplumab is a type of protein called an antibody that attacks CXCR4
Ibrutinib: Ibrutinib small-molecule inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity
|
Phase 1 Dose Level 3: Ibrutinib + Ulocuplumab 800mg Cycle 1 and 1600mg Cycles 2-6
* Ibrutinib administered orally once daily for 48 cycles
* Ulocuplumab administered intravenously at 800mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 1600mg for Cycles 2-6 on Days 1 and 15.
Ulocuplumab: Ulocuplumab is a type of protein called an antibody that attacks CXCR4
Ibrutinib: Ibrutinib small-molecule inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
3
|
|
Overall Study
COMPLETED
|
2
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
3
|
Reasons for withdrawal
| Measure |
Phase 1 Dose Level 1: Ibrutinib + Ulocuplumab 400mg Cycle 1 and 800mg Cycles 2-6
* Ibrutinib administered orally once daily for 48 cycles
* Ulocuplumab administered intravenously at 400mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 800mg for Cycles 2-6 on Days 1 and 15.
Ulocuplumab: Ulocuplumab is a type of protein called an antibody that attacks CXCR4
Ibrutinib: Ibrutinib small-molecule inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity
|
Phase 1 Dose Level 2: Ibrutinib + Ulocuplumab 800 mg Cycle 1 and 1200mg Cycles 2-6
* Ibrutinib administered orally once daily for 48 cycles
* Ulocuplumab administered intravenously at 800mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 1200mg for Cycles 2-6 on Days 1 and 15.
Ulocuplumab: Ulocuplumab is a type of protein called an antibody that attacks CXCR4
Ibrutinib: Ibrutinib small-molecule inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity
|
Phase 1 Dose Level 3: Ibrutinib + Ulocuplumab 800mg Cycle 1 and 1600mg Cycles 2-6
* Ibrutinib administered orally once daily for 48 cycles
* Ulocuplumab administered intravenously at 800mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 1600mg for Cycles 2-6 on Days 1 and 15.
Ulocuplumab: Ulocuplumab is a type of protein called an antibody that attacks CXCR4
Ibrutinib: Ibrutinib small-molecule inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
|
Overall Study
Study early termination by Sponsor
|
0
|
0
|
2
|
Baseline Characteristics
A Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated CXCR4 Waldenstrom's Macroglobulinemia
Baseline characteristics by cohort
| Measure |
Phase 1 Dose Level 1: Ibrutinib + Ulocuplumab 400mg Cycle 1 and 800mg Cycles 2-6
n=7 Participants
* Ibrutinib administered orally once daily for 48 cycles
* Ulocuplumab administered intravenously at 400mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 800mg for Cycles 2-6 on Days 1 and 15.
|
Phase 1 Dose Level 2: Ibrutinib + Ulocuplumab 800 mg Cycle 1 and 1200mg Cycles 2-6
n=3 Participants
* Ibrutinib administered orally once daily for 48 cycles
* Ulocuplumab administered intravenously at 800mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 1200mg for Cycles 2-6 on Days 1 and 15.
|
Phase 1 Dose Level 3: Ibrutinib + Ulocuplumab 800mg Cycle 1 and 1600mg Cycles 2-6
n=3 Participants
* Ibrutinib administered orally once daily for 48 cycles
* Ulocuplumab administered intravenously at 800mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 1600mg for Cycles 2-6 on Days 1 and 15.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
60 years
n=5 Participants
|
63 years
n=7 Participants
|
54 years
n=5 Participants
|
61 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 8 weeks for each dose levelMTD was determined by testing increasing doses up to 1600mg of ulocuplumab on dose escalation levels 1 to 3 with 3 to 7 participants each. MTD reflects the highest dose of ulocuplumab that did not cause a Dose-Limiting Toxicity (DLT) in \>33% of participants. DLTs were defined as any Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0) grade 4 or 5 hematologic toxicities (anemia, neutropenia, or thrombocytopenia) and grade 3 or above non-hematologic toxicities. Exceptions were allowed for toxicities attributed to underlying disease, grade 3 infection, and easily reversible asymptomatic laboratory abnormalities, and nausea, vomiting, or diarrhea controlled by medications.
Outcome measures
| Measure |
All Participants
n=13 Participants
All participants who received at least 1 dose of Ulocuplumab, either at 400mg for cycle 1 and 800mg for cycle 2+, 800mg for cycle 1 and 1200mg for cycle 2+, or 800mg for cycle 1 and 1600mg for cycle 2+
|
Phase 1 Dose Level 2: Ibrutinib + Ulocuplumab 800 mg Cycle 1 and 1200mg Cycles 2-6
* Ibrutinib administered orally once daily for 48 cycles
* Ulocuplumab administered intravenously at 800mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 1200mg for Cycles 2-6 on Days 1 and 15.
|
Phase 1 Dose Level 3: Ibrutinib + Ulocuplumab 800mg Cycle 1 and 1600mg Cycles 2-6
* Ibrutinib administered orally once daily for 48 cycles
* Ulocuplumab administered intravenously at 800mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 1600mg for Cycles 2-6 on Days 1 and 15.
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Ulocuplumab
|
1600 milligram
|
—
|
—
|
SECONDARY outcome
Timeframe: Response evaluated at each cycle day 1, starting at Cycle 2 Day 1 through Cycle 48Population: All participants who received at least 1 dose of Ulocuplumab, either at 400mg for cycle 1 and 800mg for cycle 2+, 800mg for cycle 1 and 1200mg for cycle 2+, or 800mg for cycle 1 and 1600mg for cycle 2+
Time in months to \>25%-50% reduction in serum IgM from baseline
Outcome measures
| Measure |
All Participants
n=7 Participants
All participants who received at least 1 dose of Ulocuplumab, either at 400mg for cycle 1 and 800mg for cycle 2+, 800mg for cycle 1 and 1200mg for cycle 2+, or 800mg for cycle 1 and 1600mg for cycle 2+
|
Phase 1 Dose Level 2: Ibrutinib + Ulocuplumab 800 mg Cycle 1 and 1200mg Cycles 2-6
n=3 Participants
* Ibrutinib administered orally once daily for 48 cycles
* Ulocuplumab administered intravenously at 800mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 1200mg for Cycles 2-6 on Days 1 and 15.
|
Phase 1 Dose Level 3: Ibrutinib + Ulocuplumab 800mg Cycle 1 and 1600mg Cycles 2-6
n=3 Participants
* Ibrutinib administered orally once daily for 48 cycles
* Ulocuplumab administered intravenously at 800mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 1600mg for Cycles 2-6 on Days 1 and 15.
|
|---|---|---|---|
|
Time to Minor Response
|
1 months
Interval 1.0 to 2.0
|
1 months
Interval 1.0 to 1.0
|
1 months
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: Response evaluated at each cycle day 1, starting at Cycle 2 Day 1 through Cycle 48Time in months to \>50-90% reduction in serum IgM from baseline
Outcome measures
| Measure |
All Participants
n=7 Participants
All participants who received at least 1 dose of Ulocuplumab, either at 400mg for cycle 1 and 800mg for cycle 2+, 800mg for cycle 1 and 1200mg for cycle 2+, or 800mg for cycle 1 and 1600mg for cycle 2+
|
Phase 1 Dose Level 2: Ibrutinib + Ulocuplumab 800 mg Cycle 1 and 1200mg Cycles 2-6
n=3 Participants
* Ibrutinib administered orally once daily for 48 cycles
* Ulocuplumab administered intravenously at 800mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 1200mg for Cycles 2-6 on Days 1 and 15.
|
Phase 1 Dose Level 3: Ibrutinib + Ulocuplumab 800mg Cycle 1 and 1600mg Cycles 2-6
n=3 Participants
* Ibrutinib administered orally once daily for 48 cycles
* Ulocuplumab administered intravenously at 800mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 1600mg for Cycles 2-6 on Days 1 and 15.
|
|---|---|---|---|
|
Time to Major Response
|
3 months
Interval 1.0 to 4.0
|
1 months
Interval 1.0 to 1.0
|
1 months
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: Response and progression status evaluated at each cycle day 1, starting at Cycle 2 Day 1 through Cycle 48, and every 12 weeks during follow-up for up to 2 years after end of treatmentPopulation: Of the 13 participants enrolled, only 1 participant confirmed disease progression during the study period. Median PFS was not reached. The median follow-up time before participants follow-up was terminated for each participant is reported.
Time in months until \>25% increase in serum IgM from nadir
Outcome measures
| Measure |
All Participants
n=7 Participants
All participants who received at least 1 dose of Ulocuplumab, either at 400mg for cycle 1 and 800mg for cycle 2+, 800mg for cycle 1 and 1200mg for cycle 2+, or 800mg for cycle 1 and 1600mg for cycle 2+
|
Phase 1 Dose Level 2: Ibrutinib + Ulocuplumab 800 mg Cycle 1 and 1200mg Cycles 2-6
n=3 Participants
* Ibrutinib administered orally once daily for 48 cycles
* Ulocuplumab administered intravenously at 800mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 1200mg for Cycles 2-6 on Days 1 and 15.
|
Phase 1 Dose Level 3: Ibrutinib + Ulocuplumab 800mg Cycle 1 and 1600mg Cycles 2-6
n=3 Participants
* Ibrutinib administered orally once daily for 48 cycles
* Ulocuplumab administered intravenously at 800mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 1600mg for Cycles 2-6 on Days 1 and 15.
|
|---|---|---|---|
|
Progression Free Survival (PFS)
|
20 months
Interval 3.0 to 45.0
|
43 months
Interval 35.0 to 44.0
|
37 months
Interval 15.0 to 42.0
|
Adverse Events
Phase 1 Dose Level 1: Ibrutinib + Ulocuplumab 400mg Cycle 1 and 800mg Cycles 2-6
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase 1 Dose Level 2: Ibrutinib + Ulocuplumab 800 mg Cycle 1 and 1200mg Cycles 2-6
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 Dose Level 3: Ibrutinib + Ulocuplumab 800mg Cycle 1 and 1600mg Cycles 2-6
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1 Dose Level 1: Ibrutinib + Ulocuplumab 400mg Cycle 1 and 800mg Cycles 2-6
n=7 participants at risk
* Ibrutinib administered orally once daily for 48 cycles
* Ulocuplumab administered intravenously at 400mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 800mg for Cycles 2-6 on Days 1 and 15.
|
Phase 1 Dose Level 2: Ibrutinib + Ulocuplumab 800 mg Cycle 1 and 1200mg Cycles 2-6
n=3 participants at risk
* Ibrutinib administered orally once daily for 48 cycles
* Ulocuplumab administered intravenously at 800mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 1200mg for Cycles 2-6 on Days 1 and 15.
|
Phase 1 Dose Level 3: Ibrutinib + Ulocuplumab 800mg Cycle 1 and 1600mg Cycles 2-6
n=3 participants at risk
* Ibrutinib administered orally once daily for 48 cycles
* Ulocuplumab administered intravenously at 800mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 1600mg for Cycles 2-6 on Days 1 and 15.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Brain injury from motor vehicle accident
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Infections and infestations
Pneumonia
|
14.3%
1/7 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Cardiac disorders
Atrial fibrillation
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Investigations
Neutropenia
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Investigations
Thrombocytopenia
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Cardiac disorders
Supraventricular tachycardia
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity rash
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
Other adverse events
| Measure |
Phase 1 Dose Level 1: Ibrutinib + Ulocuplumab 400mg Cycle 1 and 800mg Cycles 2-6
n=7 participants at risk
* Ibrutinib administered orally once daily for 48 cycles
* Ulocuplumab administered intravenously at 400mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 800mg for Cycles 2-6 on Days 1 and 15.
|
Phase 1 Dose Level 2: Ibrutinib + Ulocuplumab 800 mg Cycle 1 and 1200mg Cycles 2-6
n=3 participants at risk
* Ibrutinib administered orally once daily for 48 cycles
* Ulocuplumab administered intravenously at 800mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 1200mg for Cycles 2-6 on Days 1 and 15.
|
Phase 1 Dose Level 3: Ibrutinib + Ulocuplumab 800mg Cycle 1 and 1600mg Cycles 2-6
n=3 participants at risk
* Ibrutinib administered orally once daily for 48 cycles
* Ulocuplumab administered intravenously at 800mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 1600mg for Cycles 2-6 on Days 1 and 15.
|
|---|---|---|---|
|
Infections and infestations
Eye infection
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Infections and infestations
Fungal infection
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Infections and infestations
Gum infection
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Infections and infestations
Influenza
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Infections and infestations
Otitis media
|
28.6%
2/7 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Infections and infestations
Bone infection
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Infections and infestations
COVID-19
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Blood and lymphatic system disorders
Anemia
|
57.1%
4/7 • Number of events 4 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
66.7%
2/3 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Blood and lymphatic system disorders
Bleeding
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Cardiac disorders
Heart racing
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Cardiac disorders
Palpitations
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Ear and labyrinth disorders
Ear bleeding
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Ear and labyrinth disorders
Ear effusion
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Ear and labyrinth disorders
Ear granuloma
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Ear and labyrinth disorders
Ear pain
|
42.9%
3/7 • Number of events 3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Ear and labyrinth disorders
Hearing impaired
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Eye disorders
Blurred vision
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
66.7%
2/3 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Eye disorders
Corneal ulcer
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Eye disorders
Eye pain
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Eye disorders
Watering eyes
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Gastrointestinal disorders
Bloating
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Gastrointestinal disorders
Chelitiis
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Gastrointestinal disorders
Diarrhea
|
71.4%
5/7 • Number of events 5 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
66.7%
2/3 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
100.0%
3/3 • Number of events 3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
66.7%
2/3 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
66.7%
2/3 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
66.7%
2/3 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Gastrointestinal disorders
Gingival pain
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Gastrointestinal disorders
Hemorrhoids
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
42.9%
3/7 • Number of events 3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
66.7%
2/3 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Gastrointestinal disorders
Nausea
|
57.1%
4/7 • Number of events 4 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Gastrointestinal disorders
Oral pain
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
General disorders
Blood blisters
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
General disorders
Chills
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
General disorders
Edema limbs
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
General disorders
Epistaxis
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
General disorders
Fatigue
|
57.1%
4/7 • Number of events 4 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
66.7%
2/3 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
General disorders
Fever
|
28.6%
2/7 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
General disorders
Hair growing faster
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
General disorders
Heavy legs
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
General disorders
Infusion related reaction
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
General disorders
Joint effusion
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
General disorders
Localized edema
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
General disorders
Malaise
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
General disorders
Pain
|
28.6%
2/7 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
General disorders
Sciatica
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
General disorders
Temperature sensitivity
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
General disorders
Tympanic membrane perforation
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Infections and infestations
Sinusitis
|
28.6%
2/7 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Infections and infestations
Skin infection
|
42.9%
3/7 • Number of events 3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
66.7%
2/3 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Infections and infestations
Upper respiratory infection
|
57.1%
4/7 • Number of events 4 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
66.7%
2/3 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Injury, poisoning and procedural complications
Bruising
|
71.4%
5/7 • Number of events 5 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
66.7%
2/3 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Injury, poisoning and procedural complications
Tick bite
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Investigations
Platelet count decreased
|
85.7%
6/7 • Number of events 6 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
100.0%
3/3 • Number of events 3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
100.0%
3/3 • Number of events 3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
28.6%
2/7 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
28.6%
2/7 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
57.1%
4/7 • Number of events 4 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
66.7%
2/3 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
28.6%
2/7 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
57.1%
4/7 • Number of events 4 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
66.7%
2/3 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
100.0%
3/3 • Number of events 3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
42.9%
3/7 • Number of events 3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Twitching
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Nervous system disorders
Concentration impairment
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Nervous system disorders
Dizziness
|
57.1%
4/7 • Number of events 4 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
100.0%
3/3 • Number of events 3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
66.7%
2/3 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Headache
|
42.9%
3/7 • Number of events 3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Nervous system disorders
Intracranial hemorrhage
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Nervous system disorders
Jittery
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Nervous system disorders
Mouth numbness
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
28.6%
2/7 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Nervous system disorders
Sinus pain
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Psychiatric disorders
Anxiety
|
42.9%
3/7 • Number of events 3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Psychiatric disorders
Confusion
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Psychiatric disorders
Insomnia
|
28.6%
2/7 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
66.7%
2/3 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Psychiatric disorders
Mania
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Psychiatric disorders
Restlessness
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Renal and urinary disorders
Hematuria
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Renal and urinary disorders
Urinary frequency
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Renal and urinary disorders
Urinary hesitation
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Reproductive system and breast disorders
Irregular Menstruation
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
42.9%
3/7 • Number of events 3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
66.7%
2/3 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
42.9%
3/7 • Number of events 3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
28.6%
2/7 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
66.7%
2/3 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
28.6%
2/7 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Blood blisters
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Boil
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
66.7%
2/3 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
57.1%
4/7 • Number of events 4 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Irregular mole
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Onychoschizia
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
66.7%
2/3 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
66.7%
2/3 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Rash NOS
|
42.9%
3/7 • Number of events 3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
66.7%
2/3 • Number of events 2 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Stye
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Vascular disorders
Flushing
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
33.3%
1/3 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
|
Vascular disorders
Hypotension
|
14.3%
1/7 • Number of events 1 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
0.00%
0/3 • Adverse events were captured after treatment initiation and through 30 days of the last dose, up to 4 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place