Trial Outcomes & Findings for Durvalumab, Tremelimumab, and Selumetinib in Treating Participants With Recurrent or Stage IV Non-small Cell Lung Cancer (NCT NCT03581487)
NCT ID: NCT03581487
Last Updated: 2026-07-28
Results Overview
Proportion of patients achieving complete response (CR) or partial response (PR) per RECIST v1.1 criteria among evaluable participants
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
From treatment start to disease progression or last radiographic assessment (up to 20.2 months).
Results posted on
2026-07-28
Participant Flow
Patients histologically or cytologically confirmed recurrent non-small cell lung cancer not amenable to curative intent therapy or stage IV NSCLC. Documented progression following at least one line of chemotherapy or immunotherapy for metastatic or recurrent disease, or progression within 6 months of receiving adjuvant chemotherapy or concurrent chemotherapy for early stage or locally advanced disease.
Thirty-six patients were screened in phase 1 (ten screen failures), twenty-six were randomized. After establishing the RP2D of 100 mg intermittently, twenty patients were screened in phase 2 (four screen failures, two withdrew), with fourteen treated.
Participant milestones
| Measure |
Group 1: Phase 1 Continuous Selumetinib 50 mg
Participants received selumetinib 50 mg administered continuously in combination with durvalumab and tremelimumab
|
Group 2: Phase 1 Continuous Selumetinib 75 mg
Participants received selumetinib 75 mg administered continuously in combination with durvalumab and tremelimumab
|
Group 3: Phase 1 Continuous Selumetinib 100 mg
Participants received selumetinib 100 mg administered continuously in combination with durvalumab and tremelimumab
|
Group 4: Phase 1 Intermittent Selumetinib 50 mg
Participants received selumetinib 50 mg administered intermittently in combination with durvalumab and tremelimumab
|
Group 5: Phase 1 Intermittent Selumetinib 75 mg
Participants received selumetinib 75 mg administered intermittently in combination with durvalumab and tremelimumab
|
Group 6: Phase 1 Intermittent Selumetinib 100 mg
Participants received selumetinib 100 mg administered intermittently in combination with durvalumab and tremelimumab during dose escalation
|
Group 7: Phase 2 Intermittent Selumetinib 100 mg
Participants received selumetinib 100 mg administered intermittently (recommended phase 2 dose) in combination with durvalumab and tremelimumab
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
7
|
3
|
3
|
6
|
14
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
7
|
3
|
3
|
6
|
14
|
Reasons for withdrawal
| Measure |
Group 1: Phase 1 Continuous Selumetinib 50 mg
Participants received selumetinib 50 mg administered continuously in combination with durvalumab and tremelimumab
|
Group 2: Phase 1 Continuous Selumetinib 75 mg
Participants received selumetinib 75 mg administered continuously in combination with durvalumab and tremelimumab
|
Group 3: Phase 1 Continuous Selumetinib 100 mg
Participants received selumetinib 100 mg administered continuously in combination with durvalumab and tremelimumab
|
Group 4: Phase 1 Intermittent Selumetinib 50 mg
Participants received selumetinib 50 mg administered intermittently in combination with durvalumab and tremelimumab
|
Group 5: Phase 1 Intermittent Selumetinib 75 mg
Participants received selumetinib 75 mg administered intermittently in combination with durvalumab and tremelimumab
|
Group 6: Phase 1 Intermittent Selumetinib 100 mg
Participants received selumetinib 100 mg administered intermittently in combination with durvalumab and tremelimumab during dose escalation
|
Group 7: Phase 2 Intermittent Selumetinib 100 mg
Participants received selumetinib 100 mg administered intermittently (recommended phase 2 dose) in combination with durvalumab and tremelimumab
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
0
|
0
|
1
|
3
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Disease Progression
|
3
|
3
|
4
|
3
|
1
|
4
|
9
|
Baseline Characteristics
Durvalumab, Tremelimumab, and Selumetinib in Treating Participants With Recurrent or Stage IV Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Group 1: Phase 1 Continuous Selumetinib 50 mg
n=4 Participants
Participants received selumetinib 50 mg adminstered continuously in combination with durvalumab and tremelimumab
|
Group 2: Phase 1 Continuous Selumetinib 75 mg
n=3 Participants
Participants received selumetinib 75 mg adminstered continuously in combination with durvalumab and tremelimumab
|
Group 3: Phase 1 Continuous Selumetinib 100 mg
n=7 Participants
Participants received selumetinib 100 mg adminstered continuously in combination with durvalumab and tremelimumab
|
Group 4: Phase 1 Intermittent Selumetinib 50 mg
n=3 Participants
Participants received selumetinib 50 mg adminstered intermittently in combination with durvalumab and tremelimumab
|
Group 5: Phase 1 Intermittent Selumetinib 75 mg
n=3 Participants
Participants received selumetinib 75 mg adminstered intermittently in combination with durvalumab and tremelimumab
|
Group 6: Phase 1 Intermittent Selumetinib 100 mg
n=6 Participants
Participants received selumetinib 100 mg adminstered intermittently in combination with durvalumab and tremelimumab
|
Group 7: Phase 2 Intermittent Selumetinib 100 mg
n=14 Participants
Participants received selumetinib 100 mg adminstered intermittently (recommended phase 2 dose) in combination with durvalumab and tremelimumab
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
21 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
19 Participants
n=6 Participants
|
|
Age, Continuous
|
62.4 years
n=20 Participants
|
68.6 years
n=20 Participants
|
58.5 years
n=40 Participants
|
61.7 years
n=5 Participants
|
60.2 years
n=9 Participants
|
64.7 years
n=6 Participants
|
65.6 years
n=6 Participants
|
63.6 years
n=6 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
17 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
23 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
14 Participants
n=6 Participants
|
36 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
13 Participants
n=6 Participants
|
36 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=20 Participants
|
3 participants
n=20 Participants
|
7 participants
n=40 Participants
|
3 participants
n=5 Participants
|
3 participants
n=9 Participants
|
6 participants
n=6 Participants
|
14 participants
n=6 Participants
|
40 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: From treatment start to disease progression or last radiographic assessment (up to 20.2 months).Proportion of patients achieving complete response (CR) or partial response (PR) per RECIST v1.1 criteria among evaluable participants
Outcome measures
| Measure |
Group 6: Phase 1 Intermittent Selumetinib 100 mg
n=6 Participants
Participants received selumetinib 100 mg administered intermittently in combination with durvalumab and tremelimumab during dose escalation
|
Group 1: Phase 1 Continuous Selumetinib 50 mg
n=4 Participants
Participants received selumetinib 50 mg administered continuously in combination with durvalumab and tremelimumab
|
Group 2: Phase 1 Continuous Selumetinib 75 mg
n=3 Participants
Participants received selumetinib 75 mg administered continuously in combination with durvalumab and tremelimumab
|
Group 3: Phase 1 Continuous Selumetinib 100 mg
n=7 Participants
Participants received selumetinib 100 mg administered continuously in combination with durvalumab and tremelimumab
|
Group 4: Phase 1 Intermittent Selumetinib 50 mg
n=3 Participants
Participants received selumetinib 50 mg administered intermittently in combination with durvalumab and tremelimumab
|
Group 5: Phase 1 Intermittent Selumetinib 75 mg
n=3 Participants
Participants received selumetinib 75 mg administered intermittently in combination with durvalumab and tremelimumab
|
Group 7: Phase 2 Intermittent Selumetinib 100 mg
n=14 Participants
Participants received selumetinib 100 mg administered intermittently (recommended phase 2 dose) in combination with durvalumab and tremelimumab
|
|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) by RECIST v1.1
Objective Response (CR + PR)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Objective Response Rate (ORR) by RECIST v1.1
No objective response (SD + PD)
|
5 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
10 Participants
|
|
Objective Response Rate (ORR) by RECIST v1.1
Not evaluable
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From treatment start to disease progression or last radiographic assessment (up to 20.2 months).Percentage of participants with complete response (CR), partial response (PR), or stable disease (SD).
Outcome measures
| Measure |
Group 6: Phase 1 Intermittent Selumetinib 100 mg
n=6 Participants
Participants received selumetinib 100 mg administered intermittently in combination with durvalumab and tremelimumab during dose escalation
|
Group 1: Phase 1 Continuous Selumetinib 50 mg
n=4 Participants
Participants received selumetinib 50 mg administered continuously in combination with durvalumab and tremelimumab
|
Group 2: Phase 1 Continuous Selumetinib 75 mg
n=3 Participants
Participants received selumetinib 75 mg administered continuously in combination with durvalumab and tremelimumab
|
Group 3: Phase 1 Continuous Selumetinib 100 mg
n=7 Participants
Participants received selumetinib 100 mg administered continuously in combination with durvalumab and tremelimumab
|
Group 4: Phase 1 Intermittent Selumetinib 50 mg
n=3 Participants
Participants received selumetinib 50 mg administered intermittently in combination with durvalumab and tremelimumab
|
Group 5: Phase 1 Intermittent Selumetinib 75 mg
n=3 Participants
Participants received selumetinib 75 mg administered intermittently in combination with durvalumab and tremelimumab
|
Group 7: Phase 2 Intermittent Selumetinib 100 mg
n=14 Participants
Participants received selumetinib 100 mg administered intermittently (recommended phase 2 dose) in combination with durvalumab and tremelimumab
|
|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR) by RECIST v1.1
Not evaluable
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Disease Control Rate (DCR) by RECIST v1.1
Disease control (CR + PR + SD)
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
|
Disease Control Rate (DCR) by RECIST v1.1
No disease control (PD)
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 20.2 monthsTime from treatment initiation to death from any cause or last follow-up. The upper 95% confidence limit was not estimable because the corresponding survival confidence curve did not reach 50% during the observed follow-up period, and was reported as NA.
Outcome measures
| Measure |
Group 6: Phase 1 Intermittent Selumetinib 100 mg
n=6 Participants
Participants received selumetinib 100 mg administered intermittently in combination with durvalumab and tremelimumab during dose escalation
|
Group 1: Phase 1 Continuous Selumetinib 50 mg
n=4 Participants
Participants received selumetinib 50 mg administered continuously in combination with durvalumab and tremelimumab
|
Group 2: Phase 1 Continuous Selumetinib 75 mg
n=3 Participants
Participants received selumetinib 75 mg administered continuously in combination with durvalumab and tremelimumab
|
Group 3: Phase 1 Continuous Selumetinib 100 mg
n=7 Participants
Participants received selumetinib 100 mg administered continuously in combination with durvalumab and tremelimumab
|
Group 4: Phase 1 Intermittent Selumetinib 50 mg
n=3 Participants
Participants received selumetinib 50 mg administered intermittently in combination with durvalumab and tremelimumab
|
Group 5: Phase 1 Intermittent Selumetinib 75 mg
n=3 Participants
Participants received selumetinib 75 mg administered intermittently in combination with durvalumab and tremelimumab
|
Group 7: Phase 2 Intermittent Selumetinib 100 mg
n=14 Participants
Participants received selumetinib 100 mg administered intermittently (recommended phase 2 dose) in combination with durvalumab and tremelimumab
|
|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
7.9 Months
Interval 3.0 to
The 95% confidence interval was not available because the sample size in each treatment group was small and there were not enough events to estimate.
|
20.0 Months
Interval 5.8 to
The 95% confidence interval was not available because the sample size in each treatment group was small and there were not enough events to estimate.
|
16.7 Months
Interval 5.9 to
The 95% confidence interval was not available because the sample size in each treatment group was small and there were not enough events to estimate.
|
9.5 Months
Interval 2.8 to
The 95% confidence interval was not available because the sample size in each treatment group was small and there were not enough events to estimate.
|
2.8 Months
Interval 2.7 to
The 95% confidence interval was not available because the sample size in each treatment group was small and there were not enough events to estimate.
|
NA Months
Not reached
|
5.8 Months
Interval 4.1 to
The 95% confidence interval was not available because the sample size in each treatment group was small and there were not enough events to estimate.
|
SECONDARY outcome
Timeframe: Up to 20.2 monthsTime from treatment start to progression or death, whichevered occurred first, or last follow-up. The upper 95% confidence limit was not estimable because the corresponding survival confidence curve did not reach 50% during the observed follow-up period, and was reported as NA. In group 5, the lower limit of the 95% confidence intervals was not estimable because out of the 3 subjects, 2 subjects were censored, one event was observed, and it occurred when only a single subject remained at risk. Under this circumstance, Greenwood's variance was not defined at the event time. The lower limit of the confidence intervals was not estimable and was reported as NA.
Outcome measures
| Measure |
Group 6: Phase 1 Intermittent Selumetinib 100 mg
n=6 Participants
Participants received selumetinib 100 mg administered intermittently in combination with durvalumab and tremelimumab during dose escalation
|
Group 1: Phase 1 Continuous Selumetinib 50 mg
n=4 Participants
Participants received selumetinib 50 mg administered continuously in combination with durvalumab and tremelimumab
|
Group 2: Phase 1 Continuous Selumetinib 75 mg
n=3 Participants
Participants received selumetinib 75 mg administered continuously in combination with durvalumab and tremelimumab
|
Group 3: Phase 1 Continuous Selumetinib 100 mg
n=7 Participants
Participants received selumetinib 100 mg administered continuously in combination with durvalumab and tremelimumab
|
Group 4: Phase 1 Intermittent Selumetinib 50 mg
n=3 Participants
Participants received selumetinib 50 mg administered intermittently in combination with durvalumab and tremelimumab
|
Group 5: Phase 1 Intermittent Selumetinib 75 mg
n=3 Participants
Participants received selumetinib 75 mg administered intermittently in combination with durvalumab and tremelimumab
|
Group 7: Phase 2 Intermittent Selumetinib 100 mg
n=14 Participants
Participants received selumetinib 100 mg administered intermittently (recommended phase 2 dose) in combination with durvalumab and tremelimumab
|
|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS)
|
2.6 Months
Interval 0.8 to
The 95% confidence interval was not available because the sample size in each treatment group was small and there were not enough events to estimate.
|
4.2 Months
Interval 1.8 to
The 95% confidence interval was not available because the sample size in each treatment group was small and there were not enough events to estimate.
|
4.7 Months
Interval 3.9 to
The 95% confidence interval was not available because the sample size in each treatment group was small and there were not enough events to estimate.
|
7.0 Months
Interval 0.8 to
The 95% confidence interval was not available because the sample size in each treatment group was small and there were not enough events to estimate.
|
2.7 Months
Interval 2.6 to
The 95% confidence interval was not available because the sample size in each treatment group was small and there were not enough events to estimate.
|
5.6 Months
The 95% confidence interval not available in group 5 is that out of the 3 subjects, 2 subjects were censored, one event was observed, and it occurred when only a single subject remained at risk. Under this circumstance, Greenwood's variance was not defined at the event time. The lower limit of the confidence intervals was not estimable and was reported as NA.
|
4.1 Months
Interval 1.8 to 5.2
|
Adverse Events
Group 1: Phase 1 Continuous Selumetinib 50 mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Group 2: Phase 1 Continuous Selumetinib 75 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Group 3: Phase 1 Continuous Selumetinib 100 mg
Serious events: 5 serious events
Other events: 7 other events
Deaths: 5 deaths
Group 4: Phase 1 Intermittent Selumetinib 50 mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Group 5: Phase 1 Intermittent Selumetinib 75 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 6: Phase 1 Intermittent Selumetinib 100 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 4 deaths
Group 7: Phase 2 Intermittent Selumetinib 100 mg
Serious events: 3 serious events
Other events: 13 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Group 1: Phase 1 Continuous Selumetinib 50 mg
n=4 participants at risk
Participants received selumetinib 50 mg adminstered continuously in combination with durvalumab and tremelimumab
|
Group 2: Phase 1 Continuous Selumetinib 75 mg
n=3 participants at risk
Participants received selumetinib 75 mg adminstered continuously in combination with durvalumab and tremelimumab
|
Group 3: Phase 1 Continuous Selumetinib 100 mg
n=7 participants at risk
Participants received selumetinib 100 mg adminstered continuously in combination with durvalumab and tremelimumab
|
Group 4: Phase 1 Intermittent Selumetinib 50 mg
n=3 participants at risk
Participants received selumetinib 50 mg adminstered intermittently in combination with durvalumab and tremelimumab
|
Group 5: Phase 1 Intermittent Selumetinib 75 mg
n=3 participants at risk
Participants received selumetinib 75 mg adminstered intermittently in combination with durvalumab and tremelimumab
|
Group 6: Phase 1 Intermittent Selumetinib 100 mg
n=6 participants at risk
Participants received selumetinib 100 mg adminstered intermittently in combination with durvalumab and tremelimumab
|
Group 7: Phase 2 Intermittent Selumetinib 100 mg
n=14 participants at risk
Participants received selumetinib 100 mg adminstered intermittently (recommended phase 2 dose) in combination with durvalumab and tremelimumab
|
|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Acute/chronic respiratory failure with hypoxia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral Pneumonia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
Edema limbs
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Infections and infestations
Endocarditis infective
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
Fatigue
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Pnemuothorax
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
28.6%
2/7 • Number of events 3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Post obstructive pneumonia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
66.7%
2/3 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Rash
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Sepsis
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Nervous system disorders
Stroke
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Total protein decreased
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
25.0%
1/4 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Worsening pain multiple sites
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
Other adverse events
| Measure |
Group 1: Phase 1 Continuous Selumetinib 50 mg
n=4 participants at risk
Participants received selumetinib 50 mg adminstered continuously in combination with durvalumab and tremelimumab
|
Group 2: Phase 1 Continuous Selumetinib 75 mg
n=3 participants at risk
Participants received selumetinib 75 mg adminstered continuously in combination with durvalumab and tremelimumab
|
Group 3: Phase 1 Continuous Selumetinib 100 mg
n=7 participants at risk
Participants received selumetinib 100 mg adminstered continuously in combination with durvalumab and tremelimumab
|
Group 4: Phase 1 Intermittent Selumetinib 50 mg
n=3 participants at risk
Participants received selumetinib 50 mg adminstered intermittently in combination with durvalumab and tremelimumab
|
Group 5: Phase 1 Intermittent Selumetinib 75 mg
n=3 participants at risk
Participants received selumetinib 75 mg adminstered intermittently in combination with durvalumab and tremelimumab
|
Group 6: Phase 1 Intermittent Selumetinib 100 mg
n=6 participants at risk
Participants received selumetinib 100 mg adminstered intermittently in combination with durvalumab and tremelimumab
|
Group 7: Phase 2 Intermittent Selumetinib 100 mg
n=14 participants at risk
Participants received selumetinib 100 mg adminstered intermittently (recommended phase 2 dose) in combination with durvalumab and tremelimumab
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
50.0%
3/6 • Number of events 3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
57.1%
4/7 • Number of events 9 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
2/14 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Amylase increased
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Blood and lymphatic system disorders
Anemia
|
75.0%
3/4 • Number of events 3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
66.7%
2/3 • Number of events 4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
50.0%
3/6 • Number of events 3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Anxiety
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Appetite change
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Gastrointestinal disorders
Arthralgia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
50.0%
3/6 • Number of events 3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
42.9%
3/7 • Number of events 5 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
21.4%
3/14 • Number of events 3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
BUN increased
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
2/14 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
Bilateral lower extremity Edema
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
COVID
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Eye disorders
Bilateral sub-retinal and intra-retinal fluids
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Gastrointestinal disorders
Bowel Obstruction
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
CO2 increased
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
Chills
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Cholesterol high
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease with exacerbation
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Chronic right shoulder pain
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Psychiatric disorders
Confusion
|
50.0%
2/4 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
28.6%
2/7 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
66.7%
2/3 • Number of events 3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
2/6 • Number of events 3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
28.6%
2/7 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
2/6 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
2/14 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Decreased GGT
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Creatinine Decreased
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Creatinine increased
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Decreased Amylase
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Decreased Creatinine
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Decreased Lipase
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Decreased Testosterone
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Decreased lipase
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Decreased total protein
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Psychiatric disorders
Delirium
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Gastrointestinal disorders
Diarrhea
|
75.0%
3/4 • Number of events 3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
28.6%
4/14 • Number of events 4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Gastrointestinal disorders
Difficulty swallowing
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
21.4%
3/14 • Number of events 3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Eye disorders
Double vision
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Nervous system disorders
Dysgeusia
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
2/4 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
57.1%
4/7 • Number of events 4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea on Exertion (DOE)
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
Edema (joint on right hand)
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
Edema (upper lip)
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
Edema bilateral LE
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
Edema face
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
Edema limbs
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
28.6%
2/7 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
Edema lower extremities
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
Edema, BLE
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Skin and subcutaneous tissue disorders
Edema/ leg swelling
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Elevated Amylase
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Elevated GGT
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Skin and subcutaneous tissue disorders
Facial rash
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Skin and subcutaneous tissue disorders
Facial sores/rash (macular)
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
Fatigue
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
66.7%
2/3 • Number of events 3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
85.7%
6/7 • Number of events 8 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
66.7%
2/3 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
2/6 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
35.7%
5/14 • Number of events 5 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
Fever
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
28.6%
2/7 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
50.0%
3/6 • Number of events 3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Eye disorders
Floaters
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Injury, poisoning and procedural complications
Fracture
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
GGT Decrease
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
GGT increased
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
66.7%
2/3 • Number of events 3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
66.7%
2/3 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Eye disorders
Glaucoma
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Glucose increased
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Skin and subcutaneous tissue disorders
Hair Loss
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
2/6 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Vascular disorders
Hematoma
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Hemoptysis
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Gastrointestinal disorders
Hemorrhoids
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
2/6 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Increased cough
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Increased creatinine
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Gastrointestinal disorders
Indigestion
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Infusion reaction
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Itching, BLE
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
LDH elevated
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
LDH increased
|
50.0%
2/4 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Left shoulder pain
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Lipase increased
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 5 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
2/14 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
Localized edema
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
Loss of Consciousness
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Endocrine disorders
Low T3
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Vascular disorders
Lymphedema
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Lymphocyte count decreased
|
50.0%
2/4 • Number of events 3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Blood and lymphatic system disorders
Lymphocytopenia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
66.7%
2/3 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
Malaise
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Gastrointestinal disorders
Mouth sores
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
28.6%
4/14 • Number of events 4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Myoclonus
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Number of events 5 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
42.9%
3/7 • Number of events 3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
66.7%
2/3 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
50.0%
3/6 • Number of events 3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
42.9%
6/14 • Number of events 6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Nervous system disorders
Neuropath (feet)
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
Night sweats
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Numbness in feet
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
Pain
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
Pain right abdomen
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Pain, R ABD
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
66.7%
2/3 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Post nasal drip
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Skin and subcutaneous tissue disorders
Pressure ulcer to sacral region
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Protein Malnutrition
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
28.6%
2/7 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
2/6 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
21.4%
3/14 • Number of events 3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Eye disorders
Puffiness around eyes and nose
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Cardiac disorders
Pulmonary Embolism
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolus
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Rash
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
28.6%
2/7 • Number of events 4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Skin and subcutaneous tissue disorders
Rash (nose, back and legs)
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
28.6%
2/7 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
2/6 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
21.4%
3/14 • Number of events 3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
75.0%
3/4 • Number of events 3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
66.7%
2/3 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
2/6 • Number of events 3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
2/14 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Right Hip Pain
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Rt upper quadrant discomfort (spasm)
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Nervous system disorders
Seizure like attacks
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Serum amylase decreased
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Serum amylase increased
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
7.1%
1/14 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Shortness of breath
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Infections and infestations
Sinus infection
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
2/6 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Disturbance
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Psychiatric disorders
Sleep Walking
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Injury, poisoning and procedural complications
Slow wound healing
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Nervous system disorders
Somnolence
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
28.6%
2/7 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Sputum production
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Eye disorders
Swelling left eye
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
Swelling of hands and feet
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
General disorders
Swelling of the neck
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Vascular disorders
Thromboembolic event
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Eye disorders
Visual Disturbance
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
14.3%
1/7 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
66.7%
2/3 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
2/6 • Number of events 2 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
21.4%
3/14 • Number of events 3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
WBC increased
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
Weight loss
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
16.7%
1/6 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Investigations
White blood cell decreased
|
25.0%
1/4 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Worsening Pain multiple sites
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Worsening decease related pain
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
|
Eye disorders
Worsening double vision
|
0.00%
0/4 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
33.3%
1/3 • Number of events 1 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/7 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/3 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/6 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
0.00%
0/14 • From first dose of study treatment until 30 days after last dose (up to 20.2 months)
Adverse events were collected at each treatment visit and during follow-up. Events were assessed by investigators and graded according to CTCAE version 4.03
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place