Trial Outcomes & Findings for Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma (NCT NCT01755975)
NCT ID: NCT01755975
Last Updated: 2024-11-07
Results Overview
The phase Ib portion of the study is designed to determine the MTD of romidepsin and lenalidomide.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
49 participants
Primary outcome timeframe
1 year
Results posted on
2024-11-07
Participant Flow
Participant milestones
| Measure |
Dose Level -1
Romidepsin 8 mg/m\^2/Lenalidomide 10 mg
|
Dose Level 1
Romidepsin 8 mg/m\^2/Lenalidomide 15 mg
|
Dose Level 2
Romidepsin 8 mg/m\^2/Lenalidomide 25 mg
|
Dose Level 3
Romidepsin 10 mg/m\^2/Lenalidomide 25 mg
|
Dose Level 4
Romidepsin 14 mg/m\^2/Lenalidomide 25 mg
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
3
|
7
|
3
|
36
|
|
Overall Study
COMPLETED
|
0
|
3
|
6
|
3
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
Dose Level -1
Romidepsin 8 mg/m\^2/Lenalidomide 10 mg
|
Dose Level 1
Romidepsin 8 mg/m\^2/Lenalidomide 15 mg
|
Dose Level 2
Romidepsin 8 mg/m\^2/Lenalidomide 25 mg
|
Dose Level 3
Romidepsin 10 mg/m\^2/Lenalidomide 25 mg
|
Dose Level 4
Romidepsin 14 mg/m\^2/Lenalidomide 25 mg
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
2
|
Baseline Characteristics
Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma
Baseline characteristics by cohort
| Measure |
Dose Level -1
Romidepsin 8 mg/m\^2/Lenalidomide 10 mg
|
Dose Level 1
n=3 Participants
Romidepsin 8 mg/m\^2/Lenalidomide 15 mg
|
Dose Level 2
n=7 Participants
Romidepsin 8 mg/m\^2/Lenalidomide 25 mg
|
Dose Level 3
n=3 Participants
Romidepsin 10 mg/m\^2/Lenalidomide 25 mg
|
Dose Level 4
n=36 Participants
Romidepsin 14 mg/m\^2/Lenalidomide 25 mg
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
—
|
69 years
n=7 Participants
|
53 years
n=5 Participants
|
53 years
n=4 Participants
|
63 years
n=21 Participants
|
65 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
—
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
—
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
49 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
—
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
—
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
49 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: No participants treated on Dose Level -1
The phase Ib portion of the study is designed to determine the MTD of romidepsin and lenalidomide.
Outcome measures
| Measure |
Dose Level -1
Romidepsin 8 mg/m\^2/Lenalidomide 10 mg
|
Dose Level 1
n=3 Participants
Romidepsin 8 mg/m\^2/Lenalidomide 15 mg
|
Dose Level 2
n=7 Participants
Romidepsin 8 mg/m\^2/Lenalidomide 25 mg
|
Dose Level 3
n=3 Participants
Romidepsin 10 mg/m\^2/Lenalidomide 25 mg
|
Dose Level 4
n=36 Participants
Romidepsin 14 mg/m\^2/Lenalidomide 25 mg
|
|---|---|---|---|---|---|
|
Number of Dose Limiting Toxicities/DLTs
|
—
|
0 DLT's
|
1 DLT's
|
0 DLT's
|
1 DLT's
|
PRIMARY outcome
Timeframe: 1 yearPopulation: No participants treated on Dose Level -1
Subjects will be evaluated for AEs at each visit with the NCI CTCAE v4.0 used as a guide for the grading of severity.
Outcome measures
| Measure |
Dose Level -1
Romidepsin 8 mg/m\^2/Lenalidomide 10 mg
|
Dose Level 1
n=3 Participants
Romidepsin 8 mg/m\^2/Lenalidomide 15 mg
|
Dose Level 2
n=7 Participants
Romidepsin 8 mg/m\^2/Lenalidomide 25 mg
|
Dose Level 3
n=3 Participants
Romidepsin 10 mg/m\^2/Lenalidomide 25 mg
|
Dose Level 4
n=36 Participants
Romidepsin 14 mg/m\^2/Lenalidomide 25 mg
|
|---|---|---|---|---|---|
|
Number of Participants Evaluable for AEs
Not Evaluable for AEs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Evaluable for AEs
Evaluable for AEs
|
0 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: No participants treated on Dose Level -1
Overall response rate (ORR), complete response rate, very good partial response/partial response rate will be summarized using proportions and confidence intervals will be provided. 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 |
Dose Level -1
Romidepsin 8 mg/m\^2/Lenalidomide 10 mg
|
Dose Level 1
n=3 Participants
Romidepsin 8 mg/m\^2/Lenalidomide 15 mg
|
Dose Level 2
n=7 Participants
Romidepsin 8 mg/m\^2/Lenalidomide 25 mg
|
Dose Level 3
n=3 Participants
Romidepsin 10 mg/m\^2/Lenalidomide 25 mg
|
Dose Level 4
n=36 Participants
Romidepsin 14 mg/m\^2/Lenalidomide 25 mg
|
|---|---|---|---|---|---|
|
Assess the Overall Response Rate (ORR)
complete response rate, very good partial response/partial response rate
|
—
|
2 Participants
|
3 Participants
|
0 Participants
|
17 Participants
|
|
Assess the Overall Response Rate (ORR)
Stable response or progression of disease
|
—
|
1 Participants
|
4 Participants
|
3 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: No participants treated on Dose Level -1
CRR is defined as Complete Response Rate. 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 |
Dose Level -1
Romidepsin 8 mg/m\^2/Lenalidomide 10 mg
|
Dose Level 1
n=3 Participants
Romidepsin 8 mg/m\^2/Lenalidomide 15 mg
|
Dose Level 2
n=7 Participants
Romidepsin 8 mg/m\^2/Lenalidomide 25 mg
|
Dose Level 3
n=3 Participants
Romidepsin 10 mg/m\^2/Lenalidomide 25 mg
|
Dose Level 4
n=36 Participants
Romidepsin 14 mg/m\^2/Lenalidomide 25 mg
|
|---|---|---|---|---|---|
|
Complete Response Rate/CRR
Complete Response
|
—
|
1 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
|
Complete Response Rate/CRR
No Complete Response
|
—
|
2 Participants
|
6 Participants
|
3 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: up to 50 monthsPopulation: No participants treated on Dose Level -1
Duration of response (DOR), and event free survival (EFS). Time to response,duration of response and event free survival will be analyzed by routine survival analysis tools such as Kaplan-Meier estimation or competing risks method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Dose Level -1
Romidepsin 8 mg/m\^2/Lenalidomide 10 mg
|
Dose Level 1
n=3 Participants
Romidepsin 8 mg/m\^2/Lenalidomide 15 mg
|
Dose Level 2
n=7 Participants
Romidepsin 8 mg/m\^2/Lenalidomide 25 mg
|
Dose Level 3
n=3 Participants
Romidepsin 10 mg/m\^2/Lenalidomide 25 mg
|
Dose Level 4
n=36 Participants
Romidepsin 14 mg/m\^2/Lenalidomide 25 mg
|
|---|---|---|---|---|---|
|
Assess the Time to Best Response (TTBR)
Progression Free Survival/PFS
|
—
|
5.7 months
Interval 3.7 to 16.7
|
5.7 months
Interval 3.7 to 16.7
|
5.7 months
Interval 3.7 to 16.7
|
5.7 months
Interval 3.7 to 16.7
|
|
Assess the Time to Best Response (TTBR)
Overall Survival/OS
|
—
|
24.0 months
Interval 10.0 to 48.8
|
24.0 months
Interval 10.0 to 48.8
|
24.0 months
Interval 10.0 to 48.8
|
24.0 months
Interval 10.0 to 48.8
|
|
Assess the Time to Best Response (TTBR)
Duration of Response/DOR
|
—
|
15.7 months
Interval 4.1 to 26.2
|
15.7 months
Interval 4.1 to 26.2
|
15.7 months
Interval 4.1 to 26.2
|
15.7 months
Interval 4.1 to 26.2
|
|
Assess the Time to Best Response (TTBR)
Time To Best Response/TTBR
|
—
|
3.7 months
Interval 1.9 to 9.0
|
3.7 months
Interval 1.9 to 9.0
|
3.7 months
Interval 1.9 to 9.0
|
3.7 months
Interval 1.9 to 9.0
|
Adverse Events
Dose Level -1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Level 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Dose Level 2
Serious events: 7 serious events
Other events: 7 other events
Deaths: 6 deaths
Dose Level 3
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose Level 4
Serious events: 36 serious events
Other events: 36 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
Dose Level -1
Romidepsin 8 mg/m\^2/Lenalidomide 10 mg
|
Dose Level 1
n=3 participants at risk
Romidepsin 8 mg/m\^2/Lenalidomide 15 mg
|
Dose Level 2
n=7 participants at risk
Romidepsin 8 mg/m\^2/Lenalidomide 25
|
Dose Level 3
n=3 participants at risk
Romidepsin 10 mg/m\^2/Lenalidomide 25 mg
|
Dose Level 4
n=36 participants at risk
Romidepsin 14 mg/m\^2/Lenalidomide 25 mg
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Abdominal pain
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Renal and urinary disorders
Acute kidney injury
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Blood and lymphatic system disorders
Anemia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
28.6%
2/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
11.1%
4/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Metabolism and nutrition disorders
Anorexia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Infections and infestations
Appendicitis
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Ascites
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Cardiac disorders
Atrial fibrillation
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Investigations
Blood bilirubin increased
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
28.6%
2/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Psychiatric disorders
Confusion
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Constipation
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Metabolism and nutrition disorders
Dehydration
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
8.3%
3/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Diarrhea
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
8.3%
3/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Dysphagia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
11.1%
4/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
General disorders
Edema limbs
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Esophagitis
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Injury, poisoning and procedural complications
Fall
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
General disorders
Fatigue
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
28.6%
2/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
16.7%
6/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
General disorders
Fever
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
42.9%
3/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
11.1%
4/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Gastroenteritis
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
19.4%
7/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Vascular disorders
Hypotension
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Investigations
INR increased
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Infections and infestations
Lung infection
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
8.3%
3/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Infections and infestations
Mucosal infection
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Nausea
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Investigations
Neutrophil count decreased
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
11.1%
4/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Cardiac disorders
Pericardial effusion
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Investigations
Platelet count decreased
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
13.9%
5/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Infections and infestations
Pleural infection
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Nervous system disorders
Presyncope
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Infections and infestations
Rhinitis infective
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Cardiac disorders
Sinus tachycardia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Infections and infestations
Skin infection
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Nervous system disorders
Syncope
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
28.6%
2/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Vascular disorders
Thromboembolic event
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Infections and infestations
Upper respiratory infection
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Renal and urinary disorders
Urinary retention
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Injury, poisoning and procedural complications
Wound complication
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
Other adverse events
| Measure |
Dose Level -1
Romidepsin 8 mg/m\^2/Lenalidomide 10 mg
|
Dose Level 1
n=3 participants at risk
Romidepsin 8 mg/m\^2/Lenalidomide 15 mg
|
Dose Level 2
n=7 participants at risk
Romidepsin 8 mg/m\^2/Lenalidomide 25
|
Dose Level 3
n=3 participants at risk
Romidepsin 10 mg/m\^2/Lenalidomide 25 mg
|
Dose Level 4
n=36 participants at risk
Romidepsin 14 mg/m\^2/Lenalidomide 25 mg
|
|---|---|---|---|---|---|
|
Cardiac disorders
Pericardial effusion
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Eye disorders
Periorbital edema
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
66.7%
2/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
38.9%
14/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Vascular disorders
Phlebitis
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Investigations
Platelet count decreased
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
3/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
7/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
3/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
36/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Abdominal pain
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
27.8%
10/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Renal and urinary disorders
Acute kidney injury
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Investigations
Alanine aminotransferase increased
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
42.9%
3/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Investigations
Alkaline phosphatase increased
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
22.2%
8/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Immune system disorders
Allergic reaction
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
13.9%
5/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Blood and lymphatic system disorders
Anemia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
7/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
3/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
36/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Metabolism and nutrition disorders
Anorexia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
42.9%
3/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
77.8%
28/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Psychiatric disorders
Anxiety
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Infections and infestations
Appendicitis
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
8.3%
3/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Ascites
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Investigations
Aspartate aminotransferase increased
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
19.4%
7/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Cardiac disorders
Atrial fibrillation
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Immune system disorders
Autoimmune disorder
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
66.7%
2/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
8.3%
3/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Infections and infestations
Bladder infection
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Bloating
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Investigations
Blood bilirubin increased
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
7/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
8.3%
3/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Eye disorders
Blurred vision
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
11.1%
4/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Cardiac disorders
Chest pain - cardiac
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
General disorders
Chills
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Nervous system disorders
Cognitive disturbance
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Nervous system disorders
Concentration impairment
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Constipation
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
42.9%
3/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
66.7%
2/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
94.4%
34/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
3/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
41.7%
15/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Investigations
Creatinine increased
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
19.4%
7/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Metabolism and nutrition disorders
Dehydration
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Psychiatric disorders
Depression
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
8.3%
3/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Diarrhea
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
3/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
57.1%
4/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
91.7%
33/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Nervous system disorders
Dizziness
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
30.6%
11/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Eye disorders
Dry eye
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Dry mouth
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Respiratory, thoracic and mediastinal disorders
Dry skin
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
16.7%
6/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Nervous system disorders
Dysesthesia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Nervous system disorders
Dysgeusia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
66.7%
2/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
42.9%
3/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
3/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
36/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Dyspepsia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Dysphagia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
28.6%
2/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
44.4%
16/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
General disorders
Edema
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
General disorders
Edema face
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
General disorders
Edema limbs
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
27.8%
10/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Investigations
Ejection fraction decreased
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
11.1%
4/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Excess Salivation
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Eye disorders
Eye disorders - Other, specify
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Infections and infestations
Eye infection
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
General disorders
Fatigue
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
3/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
3/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
36/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
General disorders
Fever
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
7/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
30.6%
11/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Flatulence
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Injury, poisoning and procedural complications
Fracture
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Gastritis
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Reproductive system and breast disorders
Genital edema
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Eye disorders
Glaucoma
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Infections and infestations
Gum infection
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Nervous system disorders
Headache
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
66.7%
2/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
13.9%
5/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Ear and labyrinth disorders
Hearing impaired
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Renal and urinary disorders
Hematuria
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Hemorrhoids
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
8.3%
3/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
12/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
7/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
27.8%
10/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
19.4%
7/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
3/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
7/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Endocrine disorders
Hyperparathyroidism
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Vascular disorders
Hypertension
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
25.0%
9/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
25.0%
9/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
57.1%
4/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
69.4%
25/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
28.6%
2/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
8.3%
3/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
71.4%
5/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
27.8%
10/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
11.1%
4/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
7/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
36/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Endocrine disorders
Hypothyroidism
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Infections and infestations
Infections and infestations - Other, specify
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
66.7%
2/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Injury, poisoning and procedural complications
Injection site reaction
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Investigations
INR increased
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Psychiatric disorders
Insomnia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
66.7%
2/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
11.1%
4/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Musculoskeletal and connective tissue disorders
Leg Cramps
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Psychiatric disorders
Libido decreased
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Investigations
Lipase increased
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
28.6%
2/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Infections and infestations
Lung infection
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
28.6%
2/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Infections and infestations
Lymph gland infection
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Investigations
Lymphocyte count decreased
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
3/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
7/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
3/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
36/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
General disorders
Malaise
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
8.3%
3/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Mucositis oral
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal & conn tissue disorder Other, spec
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
3/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
36.1%
13/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
19.4%
7/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Nausea
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
66.7%
2/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
28.6%
2/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
36/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
8.3%
3/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Investigations
Neutrophil count decreased
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
3/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
7/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
3/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
36/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
General disorders
Non-cardiac chest pain
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Metabolism and nutrition disorders
Obesity
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Oral dysesthesia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Oral pain
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
General disorders
Pain
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
55.6%
20/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Musculoskeletal and connective tissue disorders
Pain-Shoulder
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Cardiac disorders
Palpitations
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
8.3%
3/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Nervous system disorders
Paresthesia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
8.3%
3/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Nervous system disorders
Presyncope
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
66.7%
2/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
38.9%
14/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Investigations
QTc Prolongation
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
30.6%
11/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Rectal pain
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Renal and urinary disorders
Renal calculi
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Infections and infestations
Rhinitis
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Infections and infestations
Rhinitis infective
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Infections and infestations
Sepsis
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Investigations
Serum amylase increased
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Cardiac disorders
Sinus bradycardia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Cardiac disorders
Sinus tachycardia
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Infections and infestations
Sinusitis
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disorders Other, spec
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Infections and infestations
Skin infection
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
8.3%
3/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Nervous system disorders
Syncope
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Vascular disorders
Thromboembolic event
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Infections and infestations
Tooth infection
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Nervous system disorders
Tremor
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
66.7%
2/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Infections and infestations
Upper respiratory infection
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
14.3%
1/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Renal and urinary disorders
Urinary frequency
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Renal and urinary disorders
Urinary incontinence
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Renal and urinary disorders
Urinary retention
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Renal and urinary disorders
Urinary tract pain
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Renal and urinary disorders
Urinary urgency
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Infections and infestations
Vaginal infection
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
3/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
28.6%
2/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
50.0%
18/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Eye disorders
Watering eyes
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
8.3%
3/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Investigations
Weight gain
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Investigations
Weight loss
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
3/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
42.9%
3/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
36.1%
13/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
66.7%
2/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
|
Investigations
White blood cell decreased
|
—
0/0 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
33.3%
1/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
7/7 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
66.7%
2/3 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
100.0%
36/36 • All-Cause Mortality monitored/assessed up to 5 years, Adverse Events monitored/assessed up to 1 year
No participants treated on Dose Level -1
|
Additional Information
Dr. Steven Horwitz, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-608-2680
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place