Trial Outcomes & Findings for Belantamab Mafodotin, Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Multiple Myeloma (NCT NCT04896658)
NCT ID: NCT04896658
Last Updated: 2025-04-03
Results Overview
Overall incidence and severity of Adverse Events in Number of Participants with Adverse Events in Dose Escalation
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Up to 6 weeks
Results posted on
2025-04-03
Participant Flow
Dates of the recruitment period: 12/03/2021- 01/08/2024 Types of location: UMGCCC outpatient clinic
Reasons for exclusion- history of GvHD; wears scleral lenses, Patient withdrew consent, No Measurable Disease, Inadequate organ system function, Current unstable liver disease
Participant milestones
| Measure |
Phase I: Arm A
1. Dose level 1: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 3 weeks cycles.
2. Dose level 2: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 3 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Phase 1: Arm B
1. Dose level 1: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 6 weeks cycles.
2. Dose level 2: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 6 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
|---|---|---|
|
Dose Level 1
STARTED
|
3
|
3
|
|
Dose Level 1
COMPLETED
|
3
|
3
|
|
Dose Level 1
NOT COMPLETED
|
0
|
0
|
|
Dose Level 2
STARTED
|
0
|
4
|
|
Dose Level 2
COMPLETED
|
0
|
4
|
|
Dose Level 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Total enrollment was 10. 3 patients were enrolled in Part A and 7 participants were enrolled in Part B
Baseline characteristics by cohort
| Measure |
Phase I: Arm A - Dose Level 1
n=3 Participants
(1) Dose level 1: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 3 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Phase I: Arm A - Dose Level 2
(2) Dose level 2: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 3 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Phase I: Arm B - Dose Level 1
n=3 Participants
(1) Dose level 1: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 6 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Phase I: Arm B - Dose Level 2
n=4 Participants
(2) Dose level 2: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 6 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • Total enrollment was 10. 3 patients were enrolled in Part A and 7 participants were enrolled in Part B
|
0 Participants
n=7 Participants • Total enrollment was 10. 3 patients were enrolled in Part A and 7 participants were enrolled in Part B
|
0 Participants
n=5 Participants • Total enrollment was 10. 3 patients were enrolled in Part A and 7 participants were enrolled in Part B
|
0 Participants
n=4 Participants • Total enrollment was 10. 3 patients were enrolled in Part A and 7 participants were enrolled in Part B
|
0 Participants
n=21 Participants • Total enrollment was 10. 3 patients were enrolled in Part A and 7 participants were enrolled in Part B
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants • Total enrollment was 10. 3 patients were enrolled in Part A and 7 participants were enrolled in Part B
|
0 Participants
n=7 Participants • Total enrollment was 10. 3 patients were enrolled in Part A and 7 participants were enrolled in Part B
|
0 Participants
n=5 Participants • Total enrollment was 10. 3 patients were enrolled in Part A and 7 participants were enrolled in Part B
|
1 Participants
n=4 Participants • Total enrollment was 10. 3 patients were enrolled in Part A and 7 participants were enrolled in Part B
|
1 Participants
n=21 Participants • Total enrollment was 10. 3 patients were enrolled in Part A and 7 participants were enrolled in Part B
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants • Total enrollment was 10. 3 patients were enrolled in Part A and 7 participants were enrolled in Part B
|
0 Participants
n=7 Participants • Total enrollment was 10. 3 patients were enrolled in Part A and 7 participants were enrolled in Part B
|
3 Participants
n=5 Participants • Total enrollment was 10. 3 patients were enrolled in Part A and 7 participants were enrolled in Part B
|
3 Participants
n=4 Participants • Total enrollment was 10. 3 patients were enrolled in Part A and 7 participants were enrolled in Part B
|
9 Participants
n=21 Participants • Total enrollment was 10. 3 patients were enrolled in Part A and 7 participants were enrolled in Part B
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
—
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
10 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 6 weeksPopulation: 3 patients were enrolled in Arm A, Dose Level 1. Arm A was closed due to AEs and no patients enrolled in Arm A, Dose Level 2 3 patients were enrolled in Arm B, Dose Level 1. Then 4 new patients were enrolled in Arm B, Dose Level 2. Part 2 was stopped with the FDA withdrawal of the drug approval and reluctance of patients to participate.
Overall incidence and severity of Adverse Events in Number of Participants with Adverse Events in Dose Escalation
Outcome measures
| Measure |
Arm A - Dose Level 1
n=3 Participants
(1) Dose level 1: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 3 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Arm A - Dose Level 2
(2) Dose level 2: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 3 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Arm B - Dose Level 1
n=3 Participants
(1) Dose level 1: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 6 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Arm B - Dose Level 2
n=4 Participants
(2) Dose level 2: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 6 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Phase II : Expansion Cohort
Once tolerability of the highest planned dose is established, patients will be assessed for response rate. The arm with acceptable toxicity and best response will be further assessed in the expansion cohort.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events in Dose Escalation
|
3 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Phase II of the expansion cohort was stopped with the FDA withdrawal of the drug approval and reluctance of patients to participate. 0 patients were enrolled in the Phase II expansion Cohort, therefore, there is no data to report in the data table.
Number of Participants With response rate in Dose Escalation and Expansion Cohort. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm A - Dose Level 1
n=3 Participants
(1) Dose level 1: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 3 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Arm A - Dose Level 2
(2) Dose level 2: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 3 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Arm B - Dose Level 1
n=3 Participants
(1) Dose level 1: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 6 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Arm B - Dose Level 2
n=4 Participants
(2) Dose level 2: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 6 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Phase II : Expansion Cohort
Once tolerability of the highest planned dose is established, patients will be assessed for response rate. The arm with acceptable toxicity and best response will be further assessed in the expansion cohort.
|
|---|---|---|---|---|---|
|
Response Rate in Dose Escalation and Expansion Cohort
|
3 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From date of randomization until the date of death from any cause, assessed up to 3 yearsPopulation: Phase II of the expansion cohort was stopped with the FDA withdrawal of the drug approval and reluctance of patients to participate. 0 patients were enrolled in the Phase II expansion Cohort, therefore, there is no data to report in the data table.
Number of participants with disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Arm A - Dose Level 1
n=3 Participants
(1) Dose level 1: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 3 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Arm A - Dose Level 2
(2) Dose level 2: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 3 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Arm B - Dose Level 1
n=3 Participants
(1) Dose level 1: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 6 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Arm B - Dose Level 2
n=4 Participants
(2) Dose level 2: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 6 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Phase II : Expansion Cohort
Once tolerability of the highest planned dose is established, patients will be assessed for response rate. The arm with acceptable toxicity and best response will be further assessed in the expansion cohort.
|
|---|---|---|---|---|---|
|
Number of Participants With Disease Progression
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From date of randomization until the date of death from any cause, assessed up to 3 yearsPopulation: Phase II of the expansion cohort was stopped with the FDA withdrawal of the drug approval and reluctance of patients to participate. 0 patients were enrolled in the Phase II expansion Cohort, therefore, there is no data to report in the data table.
Best Response (Not including Overall Survival (OS) response)
Outcome measures
| Measure |
Arm A - Dose Level 1
n=3 Participants
(1) Dose level 1: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 3 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Arm A - Dose Level 2
(2) Dose level 2: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 3 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Arm B - Dose Level 1
n=3 Participants
(1) Dose level 1: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 6 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Arm B - Dose Level 2
n=4 Participants
(2) Dose level 2: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 6 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Phase II : Expansion Cohort
Once tolerability of the highest planned dose is established, patients will be assessed for response rate. The arm with acceptable toxicity and best response will be further assessed in the expansion cohort.
|
|---|---|---|---|---|---|
|
Number of Participants According to Best Response
Stable Disease (SD)
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants According to Best Response
Partial Response (PR)
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Best Response
Very good partial response (VGPR)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From date of randomization until the date of death from any cause, assessed up to 3 yearsPopulation: Phase II of the expansion cohort was stopped with the FDA withdrawal of the drug approval and reluctance of patients to participate. 0 patients were enrolled in the Phase II expansion Cohort, therefore, there is no data to report in the data table.
Number of patients with overall survival response
Outcome measures
| Measure |
Arm A - Dose Level 1
n=3 Participants
(1) Dose level 1: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 3 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Arm A - Dose Level 2
(2) Dose level 2: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 3 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Arm B - Dose Level 1
n=3 Participants
(1) Dose level 1: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 6 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Arm B - Dose Level 2
n=4 Participants
(2) Dose level 2: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 6 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Phase II : Expansion Cohort
Once tolerability of the highest planned dose is established, patients will be assessed for response rate. The arm with acceptable toxicity and best response will be further assessed in the expansion cohort.
|
|---|---|---|---|---|---|
|
Overall Survival
|
2 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From date of randomization until the date of death from any cause, assessed up to 3 yearsThe cytokines were exploratory data, and were done on few patients, data is not conclusive to establish a reasonable ink with toxicity. Therefore, this endpoint cannot be provided.
Outcome measures
Outcome data not reported
Adverse Events
Phase I: Arm A - Dose Level 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase I: Arm A - Dose Level 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase I: Arm B - Dose Level 1
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I: Arm B - Dose Level 2
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase I: Arm A - Dose Level 1
n=3 participants at risk
(1) Dose level 1: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 3 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Phase I: Arm A - Dose Level 2
(2) Dose level 2: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 3 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Phase I: Arm B - Dose Level 1
n=3 participants at risk
(1) Dose level 1: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 6 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Phase I: Arm B - Dose Level 2
n=4 participants at risk
(2) Dose level 2: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 6 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Cardiac disorders
Cardiac Ablation
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Skin and subcutaneous tissue disorders
Squamous Cell Carcinoma
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Injury, poisoning and procedural complications
Fracture, Right Humerus
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
Other adverse events
| Measure |
Phase I: Arm A - Dose Level 1
n=3 participants at risk
(1) Dose level 1: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 3 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Phase I: Arm A - Dose Level 2
(2) Dose level 2: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 3 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Phase I: Arm B - Dose Level 1
n=3 participants at risk
(1) Dose level 1: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 6 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
Phase I: Arm B - Dose Level 2
n=4 participants at risk
(2) Dose level 2: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 6 weeks cycles.
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Abdominal Pain
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Infections and infestations
Acute cystitis without hematuria
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Allergic Rhinitis
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Blood and lymphatic system disorders
Anemia B12 deficiency
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Eye disorders
Blurred Vision
|
100.0%
3/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Bilateral Epithelial Edema
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Eye disorders
Bilateral hyperopic shift
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Eye disorders
bilateral Meibomian gland dysfunction
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Eye disorders
Superficial punctate keratopathy
|
66.7%
2/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Eye disorders
Bilateral Subepithelial Haze
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Eye disorders
Bilateral superficial epithelial microcyst-like changes
|
66.7%
2/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
66.7%
2/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Chills
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Chin Neuropathy
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Eye disorders
Chronic Epiretinal Membrane (right eye)
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Cold
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
50.0%
2/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Back Pain
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Eye disorders
Central Corneal cysts with overlying Punctate Epithelial Erosions [PEE]
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Cough
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Eye disorders
diffuse microcyst involving the central visual axis
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Dizziness
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Eye disorders
Dry eyes
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Dry skin rash
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Facial neuropathy
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Fatigue
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Fever
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Eye disorders
Corneal Changes
|
100.0%
3/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
66.7%
2/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Eye disorders
Ocular Toxicity
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Gum pain
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Headaches
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Hiccups
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Hip and groin pain
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Humerus fracture, left
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Hypertension
|
66.7%
2/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Blood and lymphatic system disorders
Hypokalemia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Blood and lymphatic system disorders
hypomagnesemia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Imbalance sensation
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Blood and lymphatic system disorders
Increased bilirubin
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Gastrointestinal disorders
Intermittent Gastroesophageal Reflux disease
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Leg Pain
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Muscle Cramps
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Nasal congestion
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Nausea
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
50.0%
2/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Otitis externa
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Parainfluenza Virus
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Eye disorders
Peripheral Corneal cysts with Mild Punctate Epithelial Erosions [PEE]
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Postnasal drip
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Productive cough
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Rash
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Fracture
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Hip pain
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Lesion
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Runny nose
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Blood and lymphatic system disorders
Scleral disorder
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Eye disorders
Itchy eyes
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Sore throat
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
25.0%
1/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Stomach Pain
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Gastrointestinal disorders
Upset Stomach
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
Gastrointestinal disorders
Urinary Tract Infection
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
50.0%
2/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
|
General disorders
Vitamin B6 deficiency
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
—
0/0 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
33.3%
1/3 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
0.00%
0/4 • All-Cause Mortality was assessed through study completion, up to 3 years; all adverse events were collected through 6 weeks
Arm A was stopped and 0 patients were enrolled in Arm A - Dose Level 2. Therefore, there were no participants at risk for Serious Adverse Events or for All-Cause Mortality in Arm A - Dose Level 2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place