Trial Outcomes & Findings for A Study of De-immunized DI-Leu16-IL2 Administered Subcutaneously in Participants With B-cell NHL (NCT NCT01874288)
NCT ID: NCT01874288
Last Updated: 2020-11-24
Results Overview
The MTD was determined based on toxicities from the first 2 cycles of treatment. The MTD was the highest dose tested with no more than 1 participant out of 6 experienced a dose-limiting toxicity (DLT). All non-hematologic adverse events (AEs) and all hematologic AEs of greater than Grade 3 were considered relevant to determining DLTs. DLTs included absolute lymphocyte count (ALC) Grade 3 and 4 (if ALC does not resolve to baseline grade according to Common Terminology Criteria for Adverse Events (CTCAE) v4 within 5 days post the final injection per cycle of DI-Leu16-IL2), and absolute neutrophil count (ANC) Grade 3 (If ANC does not resolve to at least Grade 2 within 5 days post the final injection per cycle of DI-Leu16-IL2) and Grade 4 (any).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
24 participants
Primary outcome timeframe
First 2 cycles of treatment (each cycle = 21 days)
Results posted on
2020-11-24
Participant Flow
Participant milestones
| Measure |
DI-Leu16-IL2 0.5 mg/m^2
Participants received DI-Leu16-IL2 0.5 milligrams per square meter (mg/m\^2) subcutaneously (SC) for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 1.0 mg/m^2
Participants received DI-Leu16-IL2 1.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 2.0 mg/m^2
Participants received DI-Leu16-IL2 2.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 4.0 mg/m^2
Participants received DI-Leu16-IL2 4.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 6.0 mg/m^2
Participants received DI-Leu16-IL2 6.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
9
|
7
|
2
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
3
|
3
|
9
|
7
|
2
|
|
Overall Study
COMPLETED
|
0
|
3
|
4
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
5
|
7
|
2
|
Reasons for withdrawal
| Measure |
DI-Leu16-IL2 0.5 mg/m^2
Participants received DI-Leu16-IL2 0.5 milligrams per square meter (mg/m\^2) subcutaneously (SC) for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 1.0 mg/m^2
Participants received DI-Leu16-IL2 1.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 2.0 mg/m^2
Participants received DI-Leu16-IL2 2.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 4.0 mg/m^2
Participants received DI-Leu16-IL2 4.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 6.0 mg/m^2
Participants received DI-Leu16-IL2 6.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Progressive disease
|
2
|
0
|
3
|
5
|
1
|
Baseline Characteristics
A Study of De-immunized DI-Leu16-IL2 Administered Subcutaneously in Participants With B-cell NHL
Baseline characteristics by cohort
| Measure |
DI-Leu16-IL2 0.5 mg/m^2
n=3 Participants
Participants received DI-Leu16-IL2 0.5 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 1.0 mg/m^2
n=3 Participants
Participants received DI-Leu16-IL2 1.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 2.0 mg/m^2
n=9 Participants
Participants received DI-Leu16-IL2 2.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 4.0 mg/m^2
n=7 Participants
Participants received DI-Leu16-IL2 4.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 6.0 mg/m^2
n=2 Participants
Participants received DI-Leu16-IL2 6.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 12.22 • n=5 Participants
|
66.7 years
STANDARD_DEVIATION 14.84 • n=7 Participants
|
64.0 years
STANDARD_DEVIATION 11.55 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 9.61 • n=4 Participants
|
57.5 years
STANDARD_DEVIATION 13.44 • n=21 Participants
|
60.9 years
STANDARD_DEVIATION 11.49 • n=10 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
|
Tumor Measurement: Sum of Product of Diameters
|
15.11667 centimeters (cm)
STANDARD_DEVIATION 9.726296 • n=5 Participants
|
12.21667 centimeters (cm)
STANDARD_DEVIATION 12.110806 • n=7 Participants
|
17.63953 centimeters (cm)
STANDARD_DEVIATION 16.388997 • n=5 Participants
|
27.95857 centimeters (cm)
STANDARD_DEVIATION 22.005858 • n=4 Participants
|
27.86500 centimeters (cm)
STANDARD_DEVIATION 10.896515 • n=21 Participants
|
20.50816 centimeters (cm)
STANDARD_DEVIATION 16.836733 • n=10 Participants
|
|
Tumor Measurement: Sum of Longest of Diameters
|
6.000 cm
STANDARD_DEVIATION 3.0414 • n=5 Participants
|
6.133 cm
STANDARD_DEVIATION 4.3524 • n=7 Participants
|
9.462 cm
STANDARD_DEVIATION 5.4068 • n=5 Participants
|
11.100 cm
STANDARD_DEVIATION 5.1901 • n=4 Participants
|
10.300 cm
STANDARD_DEVIATION 5.6569 • n=21 Participants
|
9.161 cm
STANDARD_DEVIATION 4.9829 • n=10 Participants
|
PRIMARY outcome
Timeframe: First 2 cycles of treatment (each cycle = 21 days)Population: Safety population included all enrolled participants who received at least 1 dose of study drug.
The MTD was determined based on toxicities from the first 2 cycles of treatment. The MTD was the highest dose tested with no more than 1 participant out of 6 experienced a dose-limiting toxicity (DLT). All non-hematologic adverse events (AEs) and all hematologic AEs of greater than Grade 3 were considered relevant to determining DLTs. DLTs included absolute lymphocyte count (ALC) Grade 3 and 4 (if ALC does not resolve to baseline grade according to Common Terminology Criteria for Adverse Events (CTCAE) v4 within 5 days post the final injection per cycle of DI-Leu16-IL2), and absolute neutrophil count (ANC) Grade 3 (If ANC does not resolve to at least Grade 2 within 5 days post the final injection per cycle of DI-Leu16-IL2) and Grade 4 (any).
Outcome measures
| Measure |
DI-Leu16-IL2
n=24 Participants
Participants received assigned doses of DI-Leu16-IL2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 1.0 mg/m^2
Participants received DI-Leu16-IL2 1.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 2.0 mg/m^2
Participants received DI-Leu16-IL2 2.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 4.0 mg/m^2
Participants received DI-Leu16-IL2 4.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 6.0 mg/m^2
Participants received DI-Leu16-IL2 6.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of DI-Leu16-IL2
|
4.0 mg/m^2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: First 2 cycles of treatment (each cycle = 21 days)Population: Safety population included all enrolled participants who received at least 1 dose of study drug.
All non-hematologic AEs and all hematologic AEs of greater than Grade 3 were considered relevant to determining DLTs. DLTs included ALC Grade 3 and 4 (if ALC does not resolve to baseline grade according to CTCAE v4 within 5 days post the final injection per cycle of DI-Leu16-IL2), and ANC Grade 3 (If ANC does not resolve to at least Grade 2 within 5 days post the final injection per cycle of DI-Leu16-IL2) and Grade 4 (any).
Outcome measures
| Measure |
DI-Leu16-IL2
n=3 Participants
Participants received assigned doses of DI-Leu16-IL2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 1.0 mg/m^2
n=3 Participants
Participants received DI-Leu16-IL2 1.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 2.0 mg/m^2
n=9 Participants
Participants received DI-Leu16-IL2 2.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 4.0 mg/m^2
n=7 Participants
Participants received DI-Leu16-IL2 4.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 6.0 mg/m^2
n=2 Participants
Participants received DI-Leu16-IL2 6.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
|---|---|---|---|---|---|
|
Number of Participants With a DLT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: First dose of study drug until first appearance of CR, CRu, PR, SD, or PD (up to 6 months)Population: Safety population included all enrolled participants who received at least 1 dose of study drug.
BOR included complete response (CR), unconfirmed CR (CRu), partial response (PR), stable disease (SD), and progressive disease (PD). CR: 1) Disappearance of all detectable clinical and radiological evidence of disease; 2) lymph nodes (LN) regressed to normal size; 3) other organs (spleen, liver, kidneys) that were enlarged before therapy must have decreased in size; 4) clear bone marrow (BM) infiltrate. CRu: must meet CR criteria 1 and 3, as well as ≥1 of following: residual LN mass \>1.5 cm in greatest transverse diameter; individual nodes that were previously confluent regressed by \>75% in sum of product diameters (SPD); or indeterminate BM. PR: 6 largest dominant nodes or nodal masses decreased by ≤50% in SPD; no increase in size of other nodes; liver or spleen; splenic and hepatic nodules regressed ≥50% in SPD; and no new disease. SD: less than a PR but not PD. PD: 50% increase from nadir in SPD of any abnormal node for PR or nonresponders and appearance of any new lesion.
Outcome measures
| Measure |
DI-Leu16-IL2
n=3 Participants
Participants received assigned doses of DI-Leu16-IL2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 1.0 mg/m^2
n=3 Participants
Participants received DI-Leu16-IL2 1.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 2.0 mg/m^2
n=9 Participants
Participants received DI-Leu16-IL2 2.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 4.0 mg/m^2
n=7 Participants
Participants received DI-Leu16-IL2 4.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 6.0 mg/m^2
n=2 Participants
Participants received DI-Leu16-IL2 6.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
|---|---|---|---|---|---|
|
Number of Participants With Best Overall Response (BOR) Assessed Per International Workshop for Non-Hodgkin Lymphoma (NHL) Response Criteria
CR
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Best Overall Response (BOR) Assessed Per International Workshop for Non-Hodgkin Lymphoma (NHL) Response Criteria
CRu
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Best Overall Response (BOR) Assessed Per International Workshop for Non-Hodgkin Lymphoma (NHL) Response Criteria
PR
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Best Overall Response (BOR) Assessed Per International Workshop for Non-Hodgkin Lymphoma (NHL) Response Criteria
SD
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Best Overall Response (BOR) Assessed Per International Workshop for Non-Hodgkin Lymphoma (NHL) Response Criteria
PD
|
1 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline, end of study (EOS) (up to approximately 3 years)Population: Safety population included all enrolled participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.
Sum of product diameters sums the product of the 2 tumor measurements on each lesion. If only 1 measurement was available, it was used as the longest length and the product of the lengths in the sum. Baseline value is the last non-missing measurement prior to receiving study drug injection. None of the participants were considered evaluable in 'DI-Leu16-IL2 0.5 mg/m\^2' arm for this outcome measure at the end of study, and therefore, data were not collected for that arm.
Outcome measures
| Measure |
DI-Leu16-IL2
Participants received assigned doses of DI-Leu16-IL2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 1.0 mg/m^2
n=3 Participants
Participants received DI-Leu16-IL2 1.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 2.0 mg/m^2
n=5 Participants
Participants received DI-Leu16-IL2 2.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 4.0 mg/m^2
n=5 Participants
Participants received DI-Leu16-IL2 4.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 6.0 mg/m^2
n=2 Participants
Participants received DI-Leu16-IL2 6.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
|---|---|---|---|---|---|
|
Tumor Measurement: Percent Change From Baseline in Sum of Product of Diameters at the End of Study
|
—
|
-31.54881 percent change
Standard Deviation 60.445273
|
-26.37248 percent change
Standard Deviation 78.719865
|
48.83017 percent change
Standard Deviation 120.291120
|
87.98408 percent change
Standard Deviation 78.864919
|
PRIMARY outcome
Timeframe: Baseline, EOS (up to approximately 3 years)Population: Safety population included all enrolled participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.
Sum of longest diameters is the sum of the longest measured length of each tumor lesion. Baseline value is the last non-missing measurement prior to receiving study drug injection. None of the participants were considered evaluable in 'DI-Leu16-IL2 0.5 mg/m\^2' arm for this outcome measure at the end of study, and therefore, data were not collected for that arm.
Outcome measures
| Measure |
DI-Leu16-IL2
Participants received assigned doses of DI-Leu16-IL2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 1.0 mg/m^2
n=3 Participants
Participants received DI-Leu16-IL2 1.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 2.0 mg/m^2
n=5 Participants
Participants received DI-Leu16-IL2 2.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 4.0 mg/m^2
n=5 Participants
Participants received DI-Leu16-IL2 4.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 6.0 mg/m^2
n=2 Participants
Participants received DI-Leu16-IL2 6.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
|---|---|---|---|---|---|
|
Tumor Measurement: Percent Change From Baseline in Sum of Longest Diameters at the End of Study
|
—
|
-30.657 percent change
Standard Deviation 60.3132
|
-27.412 percent change
Standard Deviation 49.2553
|
1.398 percent change
Standard Deviation 43.4731
|
28.516 percent change
Standard Deviation 22.5263
|
SECONDARY outcome
Timeframe: First dose of study drug up to EOS (up to approximately 3 years)Population: Due to early termination of study, data for this outcome measure were not collected.
Outcome measures
Outcome data not reported
Adverse Events
DI-Leu16-IL2 0.5 mg/m^2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
DI-Leu16-IL2 1.0 mg/m^2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
DI-Leu16-IL2 2.0 mg/m^2
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
DI-Leu16-IL2 4.0 mg/m^2
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
DI-Leu16-IL2 6.0 mg/m^2
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DI-Leu16-IL2 0.5 mg/m^2
n=3 participants at risk
Participants received DI-Leu16-IL2 0.5 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 1.0 mg/m^2
n=3 participants at risk
Participants received DI-Leu16-IL2 1.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 2.0 mg/m^2
n=9 participants at risk
Participants received DI-Leu16-IL2 2.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 4.0 mg/m^2
n=7 participants at risk
Participants received DI-Leu16-IL2 4.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 6.0 mg/m^2
n=2 participants at risk
Participants received DI-Leu16-IL2 6.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
2/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
DI-Leu16-IL2 0.5 mg/m^2
n=3 participants at risk
Participants received DI-Leu16-IL2 0.5 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 1.0 mg/m^2
n=3 participants at risk
Participants received DI-Leu16-IL2 1.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 2.0 mg/m^2
n=9 participants at risk
Participants received DI-Leu16-IL2 2.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 4.0 mg/m^2
n=7 participants at risk
Participants received DI-Leu16-IL2 4.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
DI-Leu16-IL2 6.0 mg/m^2
n=2 participants at risk
Participants received DI-Leu16-IL2 6.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
|
|---|---|---|---|---|---|
|
Eye disorders
Dry eye
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Sleep disorder due to general medical condition, insomnia Type
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site erythema
|
66.7%
2/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
100.0%
3/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
77.8%
7/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
85.7%
6/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
100.0%
2/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site pruritus
|
100.0%
3/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
100.0%
3/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
66.7%
6/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
57.1%
4/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Chills
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
55.6%
5/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
100.0%
7/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
100.0%
2/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
44.4%
4/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
2/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
100.0%
3/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
44.4%
4/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
85.7%
6/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
55.6%
5/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
42.9%
3/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
100.0%
2/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site induration
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
66.7%
2/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
44.4%
4/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
42.9%
3/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site rash
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
3/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
57.1%
4/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
100.0%
3/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
42.9%
3/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site pain
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
66.7%
2/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
66.7%
2/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site oedema
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
3/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
55.6%
5/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
2/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
44.4%
4/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
42.9%
3/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
42.9%
3/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
3/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
66.7%
2/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
66.7%
6/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
71.4%
5/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
3/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
100.0%
2/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
100.0%
2/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
100.0%
2/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
3/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
2/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
55.6%
5/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
42.9%
3/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
2/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
2/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
66.7%
2/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
100.0%
2/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
2/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
66.7%
2/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
44.4%
4/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
2/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
100.0%
2/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
2/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site swelling
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site discolouration
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
3/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site inflammation
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site warmth
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
66.7%
2/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Local swelling
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Face oedema
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Feeling cold
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Infusion site haematoma
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site anaesthesia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site discomfort
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site dryness
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site mass
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site nodule
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site vesicles
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Thirst
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
66.7%
2/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
66.7%
2/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Faeces discoloured
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
2/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
66.7%
2/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
2/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
2/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Weight increased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
2/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood glucose increased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood potassium increased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Cardiac murmur
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Electrocardiogram QT interval
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
General physical condition abnormal
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Mean cell haemoglobin decreased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Protein total increased
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
66.7%
2/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Central obesity
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
2/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
2/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
2/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
2/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin hypertrophy
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
2/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
2/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
1/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
2/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
2/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
2/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
2/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
2/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
1/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Diplopia
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
66.7%
2/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Incision site pruritus
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-hodgkin's lymphoma
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Sinus operation
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
1/9 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/7 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/2 • First dose of study drug up to EOS (up to approximately 3 years)
Safety population included all enrolled participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60