Trial Outcomes & Findings for A Study Of The Selective PKC-β Inhibitor MS- 553 (NCT NCT03492125)
NCT ID: NCT03492125
Last Updated: 2025-04-10
Results Overview
DLT are defined as any of the following treatment-emergent events occurring during the DLT evaluation period. 1. Death 2. Hematologic toxicities: • Grade 4 neutropenia for ≥ 7 days • Grade 3 febrile neutropenia: absolute neutrophil count (ANC) 38.3°C (101°F) or a sustained temperature ≥38°C (100.4°F) for \> 1 hour • Grade 4 thrombocytopenia ≥ 14 days (patients with baseline platelet count of ≥ 50 x 109 /L) • Grade 4 thrombocytopenia ≥ 28 days (patients with baseline platelet count \< 50 x 10 9 /L) • ≥ Grade 3 thrombocytopenia associated with ≥ Grade 2 hemorrhage • New ≥ Grade 3 anemia requiring transfusion in a patient previously transfusion independent. 3. Nonhematologic toxicities: • Any other ≥ Grade 3 toxicity not reversed to any one of the following three conditions in 7 days with appropriate intervention: a) baseline; b) \< Grade 1; or c) a status considered to be controlled by the SRC. • Any TEAE requiring \>25% of doses of scheduled study drug to be withheld during the DLT period
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Assessments for DLT and TEAE will occur during Cycle 1 (28 days) for A1 Cohort and B1 Cohort and Cycles 1-4 (up to 112 days) for C1 Cohort.
Results posted on
2025-04-10
Participant Flow
Participants enrolled between May 2018 and Oct. 2023
No participants were enrolled in Cohort B2, B3 or C2
Participant milestones
| Measure |
Phase I Dose Escalation Cohort A1 (MS-553:100 mg BID)
R/R CLL/SLL patients MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 200 mg BID)
Refractory/Relapsed CLL/SLL patients MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 250 mg BID)
Refractory/Relapsed CLL/SLL patients MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 300 mg BID)
Refractory/Relapsed CLL/SLL patients MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 350 mg BID)
Refractory/Relapsed CLL/SLL patients MS-553 Monotherapy: Oral
|
Phase II Expansion Cohort A2 (MS-553 Monotherapy)
R/R CLL/SLL patients
MS-553: Oral recommended phase 2 dose of MS-553
|
Phase II Expansion Cohort A3 (MS-553 Monotherapy)
patients with Richter's transformation or aggressive lymphoma
MS-553: Oral recommended phase 2 dose of MS-553
|
Phase I Combination Dose Escalation Cohort B1 (MS-553: 150 mg BID)
BTK inhibitor naïve CLL/SLL patients MS-553: Oral acalabrutinib: Oral
|
Phase I Combination Dose Escalation Cohort B1 (MS: 553: 200 mg BID)
BTK inhibitor naïve CLL/SLL patients MS-553: Oral acalabrutinib: Oral
|
Phase I Combination Dose Escalation Cohort C1 (MS-553: 150 mg BID)
Bcl-2 inhibitor naïve CLL/SLL patients
MS-553: Oral venetoclax: Oral Rituximab: IV obinutuzumab: IV
|
Phase I Combination Dose Escalation Cohort C1 (MS-553: 200 mg BID)
Bcl-2 inhibitor naïve CLL/SLL patients MS-553: Oral venetoclax: Oral Rituximab: IV obinutuzumab: IV
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
DLT Evaluation Period
STARTED
|
4
|
3
|
3
|
4
|
4
|
0
|
0
|
3
|
3
|
3
|
4
|
|
DLT Evaluation Period
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
0
|
0
|
3
|
3
|
3
|
3
|
|
DLT Evaluation Period
NOT COMPLETED
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Dose Expansion Period
STARTED
|
0
|
0
|
0
|
0
|
0
|
23
|
6
|
0
|
0
|
0
|
0
|
|
Dose Expansion Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
20
|
5
|
0
|
0
|
0
|
0
|
|
Dose Expansion Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Of The Selective PKC-β Inhibitor MS- 553
Baseline characteristics by cohort
| Measure |
Phase I Dose Escalation Cohort A1 (MS-553: 100 mg BID)
n=4 Participants
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 200 mg BID)
n=3 Participants
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 250 mg BID)
n=3 Participants
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 300 mg BID)
n=4 Participants
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 350 mg BID)
n=4 Participants
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase II Expansion Cohort A2 (MS-553 Monotherapy)
n=23 Participants
R/R CLL/SLL patients
MS-553: Oral recommended phase 2 dose of MS-553
|
Phase II Expansion Cohort A3 (MS-553 Monotherapy)
n=6 Participants
patients with Richter's transformation or aggressive lymphoma
MS-553: Oral recommended phase 2 dose of MS-553
|
Phase I Combination Dose Escalation Cohort B1 (MS-553: 150 mg BID)
n=3 Participants
BTK inhibitor naïve CLL/SLL patients
MS-553: Oral
acalabrutinib: Oral
|
Phase I Combination Dose Escalation Cohort B1 (MS-553:200 mg BID)
n=3 Participants
BTK inhibitor naïve CLL/SLL patients
MS-553: Oral
acalabrutinib: Oral
|
Phase I Combination Dose Escalation Cohort C1 (MS-553: 150 mg BID)
n=3 Participants
Bcl-2 inhibitor naïve CLL/SLL patients
MS-553: Oral
venetoclax: Oral
Rituximab: IV
obinutuzumab: IV
|
Phase I Combination Dose Escalation Cohort C1 (MS-553: 200 mg BID)
n=4 Participants
Bcl-2 inhibitor naïve CLL/SLL patients
MS-553: Oral
venetoclax: Oral
Rituximab: IV
obinutuzumab: IV
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
48 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
21 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
39 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
56 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
57 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
4 participants
n=21 Participants
|
23 participants
n=8 Participants
|
6 participants
n=8 Participants
|
3 participants
n=24 Participants
|
3 participants
n=42 Participants
|
3 participants
n=42 Participants
|
4 participants
n=42 Participants
|
60 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Assessments for DLT and TEAE will occur during Cycle 1 (28 days) for A1 Cohort and B1 Cohort and Cycles 1-4 (up to 112 days) for C1 Cohort.Population: DLT evaluable population (Phase 1 only) included all participants who had completed at least 75% of their planned doses during Cycle 1 or the DLT period, unless missed doses were due to adverse events.
DLT are defined as any of the following treatment-emergent events occurring during the DLT evaluation period. 1. Death 2. Hematologic toxicities: • Grade 4 neutropenia for ≥ 7 days • Grade 3 febrile neutropenia: absolute neutrophil count (ANC) 38.3°C (101°F) or a sustained temperature ≥38°C (100.4°F) for \> 1 hour • Grade 4 thrombocytopenia ≥ 14 days (patients with baseline platelet count of ≥ 50 x 109 /L) • Grade 4 thrombocytopenia ≥ 28 days (patients with baseline platelet count \< 50 x 10 9 /L) • ≥ Grade 3 thrombocytopenia associated with ≥ Grade 2 hemorrhage • New ≥ Grade 3 anemia requiring transfusion in a patient previously transfusion independent. 3. Nonhematologic toxicities: • Any other ≥ Grade 3 toxicity not reversed to any one of the following three conditions in 7 days with appropriate intervention: a) baseline; b) \< Grade 1; or c) a status considered to be controlled by the SRC. • Any TEAE requiring \>25% of doses of scheduled study drug to be withheld during the DLT period
Outcome measures
| Measure |
Phase I Dose Escalation Cohort A1 (MS-553: 100mg BID)
n=3 Participants
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 200mg BID)
n=3 Participants
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 250mg BID)
n=3 Participants
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 300mg BID)
n=3 Participants
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 350mg BID)
n=4 Participants
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase I Combination Dose Escalation Cohort B1 (MS-553: 150 mg BID)
n=3 Participants
BTK inhibitor naïve CLL/SLL patients
MS-553: Oral
acalabrutinib: Oral
|
Phase I Combination Dose Escalation Cohort B1 (MS-553-200 mg BID)
n=2 Participants
BTK inhibitor naïve CLL/SLL patients
MS-553: Oral
acalabrutinib: Oral
|
Phase I Combination Dose Escalation Cohort C1 (MS-553: 150 mg BID)
n=3 Participants
Bcl-2 inhibitor naïve CLL/SLL patients
MS-553: Oral
venetoclax: Oral
Rituximab: IV
obinutuzumab: IV
|
Phase I Combination Dose Escalation Cohort C1 (MS-553: 200 mg BID)
n=4 Participants
Bcl-2 inhibitor naïve CLL/SLL patients
MS-553: Oral
venetoclax: Oral
Rituximab: IV
obinutuzumab: IV
|
Phase I Combination Dose Escalation Cohort C1 (MS-553: 150 mg BID)
Bcl-2 inhibitor naïve CLL/SLL patients
MS-553: Oral venetoclax: Oral Rituximab: IV obinutuzumab: IV
|
Phase I Combination Dose Escalation Cohort C1 (MS-553: 200 mg BID)
Bcl-2 inhibitor naïve CLL/SLL patients
MS-553: Oral venetoclax: Oral Rituximab: IV obinutuzumab: IV
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Incidence Rate of DLT and TEAE Requiring Study Drug Discontinuation
Number of participants with DLT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
The Incidence Rate of DLT and TEAE Requiring Study Drug Discontinuation
Number of participants with TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Evaluation of the efficacy endpoints related to response will incorporate the data from the first 9 cycles (up to 252 days) of treatment.Population: Consisting of all patients who received at least one dose of study therapy of MS-553 and had at least one post-baseline efficacy evaluation.
This will be assessed according to the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Response Criteria with modifications for treatment-related lymphocytosis. Any patient who receives at least one cycle of study therapy is evaluable for response.
Outcome measures
| Measure |
Phase I Dose Escalation Cohort A1 (MS-553: 100mg BID)
n=3 Participants
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 200mg BID)
n=3 Participants
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 250mg BID)
n=3 Participants
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 300mg BID)
n=3 Participants
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 350mg BID)
n=3 Participants
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase I Combination Dose Escalation Cohort B1 (MS-553: 150 mg BID)
n=19 Participants
BTK inhibitor naïve CLL/SLL patients
MS-553: Oral
acalabrutinib: Oral
|
Phase I Combination Dose Escalation Cohort B1 (MS-553-200 mg BID)
n=4 Participants
BTK inhibitor naïve CLL/SLL patients
MS-553: Oral
acalabrutinib: Oral
|
Phase I Combination Dose Escalation Cohort C1 (MS-553: 150 mg BID)
n=3 Participants
Bcl-2 inhibitor naïve CLL/SLL patients
MS-553: Oral
venetoclax: Oral
Rituximab: IV
obinutuzumab: IV
|
Phase I Combination Dose Escalation Cohort C1 (MS-553: 200 mg BID)
n=3 Participants
Bcl-2 inhibitor naïve CLL/SLL patients
MS-553: Oral
venetoclax: Oral
Rituximab: IV
obinutuzumab: IV
|
Phase I Combination Dose Escalation Cohort C1 (MS-553: 150 mg BID)
n=3 Participants
Bcl-2 inhibitor naïve CLL/SLL patients
MS-553: Oral venetoclax: Oral Rituximab: IV obinutuzumab: IV
|
Phase I Combination Dose Escalation Cohort C1 (MS-553: 200 mg BID)
n=3 Participants
Bcl-2 inhibitor naïve CLL/SLL patients
MS-553: Oral venetoclax: Oral Rituximab: IV obinutuzumab: IV
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
The ORR of MS-553 in Patients With CLL/SLL Whose Disease Relapsed After or Was Refractory to at Least One Prior Therapy
|
0 percentage of participants
|
33.3 percentage of participants
|
100 percentage of participants
|
66.7 percentage of participants
|
33.3 percentage of participants
|
42.10 percentage of participants
|
25 percentage of participants
|
100 percentage of participants
|
66.7 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
Adverse Events
Phase I Dose Escalation Cohort A1 (MS-553: 100 mg BID)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Phase I Dose Escalation Cohort A1 (MS-553: 200 mg BID)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase I Dose Escalation Cohort A1 (MS-553: 250 mg BID)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase I Dose Escalation Cohort A1 (MS-553: 300 mg BID)
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Phase I Dose Escalation Cohort A1 (MS-553: 350 mg BID)
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Phase II Expansion Cohort A2 (MS-553 Monotherapy)
Serious events: 15 serious events
Other events: 23 other events
Deaths: 6 deaths
Phase II Expansion Cohort A3 (MS-553 Monotherapy)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 3 deaths
Phase I Combination Dose Escalation Cohort B1 (MS-553: 150 mg BID)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I Combination Dose Escalation Cohort B1 (MS-553: 200 mg BID)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I Combination Dose Escalation Cohort C1 (MS-553: 150 mg BID)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I Combination Dose Escalation Cohort C1 (MS-553: 200 mg BID)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I Dose Escalation Cohort A1 (MS-553: 100 mg BID)
n=4 participants at risk
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 200 mg BID)
n=3 participants at risk
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 250 mg BID)
n=3 participants at risk
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 300 mg BID)
n=4 participants at risk
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 350 mg BID)
n=4 participants at risk
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase II Expansion Cohort A2 (MS-553 Monotherapy)
n=23 participants at risk
R/R CLL/SLL patients
MS-553: Oral recommended phase 2 dose of MS-553
|
Phase II Expansion Cohort A3 (MS-553 Monotherapy)
n=6 participants at risk
patients with Richter's transformation or aggressive lymphoma
MS-553: Oral recommended phase 2 dose of MS-553
|
Phase I Combination Dose Escalation Cohort B1 (MS-553: 150 mg BID)
n=3 participants at risk
BTK inhibitor naïve CLL/SLL patients
MS-553: Oral
acalabrutinib: Oral
|
Phase I Combination Dose Escalation Cohort B1 (MS-553: 200 mg BID)
n=3 participants at risk
BTK inhibitor naïve CLL/SLL patients
MS-553: Oral
acalabrutinib: Oral
|
Phase I Combination Dose Escalation Cohort C1 (MS-553: 150 mg BID)
n=3 participants at risk
Bcl-2 inhibitor naïve CLL/SLL patients
MS-553: Oral
venetoclax: Oral
Rituximab: IV
obinutuzumab: IV
|
Phase I Combination Dose Escalation Cohort C1 (MS-553: 200 mg BID)
n=4 participants at risk
Bcl-2 inhibitor naïve CLL/SLL patients
MS-553: Oral
venetoclax: Oral
Rituximab: IV
obinutuzumab: IV
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
16.7%
1/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
16.7%
1/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
16.7%
1/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Pyrexia
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
13.0%
3/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Sudden death
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Disease progression
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Pneumonia parainfluenzae viral
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Enterocolitis infectious
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Abscess limb
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Renal and urinary disorders
Acute kidney injury
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
16.7%
1/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Vascular disorders
Aortic thrombosis
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Vascular disorders
Arterial thrombosis
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Vascular disorders
Embolism arterial
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
Other adverse events
| Measure |
Phase I Dose Escalation Cohort A1 (MS-553: 100 mg BID)
n=4 participants at risk
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 200 mg BID)
n=3 participants at risk
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 250 mg BID)
n=3 participants at risk
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 300 mg BID)
n=4 participants at risk
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase I Dose Escalation Cohort A1 (MS-553: 350 mg BID)
n=4 participants at risk
R/R CLL/SLL patients
MS-553 Monotherapy: Oral
|
Phase II Expansion Cohort A2 (MS-553 Monotherapy)
n=23 participants at risk
R/R CLL/SLL patients
MS-553: Oral recommended phase 2 dose of MS-553
|
Phase II Expansion Cohort A3 (MS-553 Monotherapy)
n=6 participants at risk
patients with Richter's transformation or aggressive lymphoma
MS-553: Oral recommended phase 2 dose of MS-553
|
Phase I Combination Dose Escalation Cohort B1 (MS-553: 150 mg BID)
n=3 participants at risk
BTK inhibitor naïve CLL/SLL patients
MS-553: Oral
acalabrutinib: Oral
|
Phase I Combination Dose Escalation Cohort B1 (MS-553: 200 mg BID)
n=3 participants at risk
BTK inhibitor naïve CLL/SLL patients
MS-553: Oral
acalabrutinib: Oral
|
Phase I Combination Dose Escalation Cohort C1 (MS-553: 150 mg BID)
n=3 participants at risk
Bcl-2 inhibitor naïve CLL/SLL patients
MS-553: Oral
venetoclax: Oral
Rituximab: IV
obinutuzumab: IV
|
Phase I Combination Dose Escalation Cohort C1 (MS-553: 200 mg BID)
n=4 participants at risk
Bcl-2 inhibitor naïve CLL/SLL patients
MS-553: Oral
venetoclax: Oral
Rituximab: IV
obinutuzumab: IV
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Coordination and balance disturbances
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Cortical dysfunction NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Joint related signs and symptoms
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Muscle pains
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Muscle related signs and symptoms NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
16.7%
1/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness conditions
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
75.0%
3/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue conditions NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue pain and discomfort
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
17.4%
4/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
16.7%
1/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Soft tissue disorders NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Spine and neck deformities
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphomas
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endocrine neoplasms malignant and unspecified NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin neoplasms benign
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin neoplasms malignant and unspecified (excl melanoma)
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Auditory nerve disorders
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Central nervous system haemorrhages and cerebrovascular accidents
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Disturbances in consciousness NEC
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
13.0%
3/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Dyskinesias and movement disorders NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Encephalopathies NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Headaches NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
16.7%
1/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Lumbar spinal cord and nerve root disorders
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Memory loss (excl dementia)
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Mental impairment (excl dementia and memory loss)
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Mononeuropathies
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Neurological signs and symptoms NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
30.4%
7/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
2/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Olfactory nerve disorders
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Paraesthesias and dysaesthesias
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
21.7%
5/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
75.0%
3/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Peripheral neuropathies NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
39.1%
9/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Sensory abnormalities NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
13.0%
3/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Psychiatric disorders
Anxiety symptoms
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
13.0%
3/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Psychiatric disorders
Confusion and disorientation
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Psychiatric disorders
Deliria
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Psychiatric disorders
Depressive disorders
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Psychiatric disorders
Disturbances in initiating and maintaining sleep
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Psychiatric disorders
Increased physical activity levels
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Psychiatric disorders
Sleep disorders NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Renal and urinary disorders
Bladder and urethral symptoms
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Renal and urinary disorders
Renal failure and impairment
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Renal and urinary disorders
Urinary abnormalities
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Reproductive system and breast disorders
Prostatic neoplasms and hypertrophy
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Breathing abnormalities
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
75.0%
3/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
21.7%
5/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial conditions NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm and obstruction
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Conditions associated with abnormal gas exchange
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Coughing and associated symptoms
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
100.0%
3/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
13.0%
3/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
75.0%
3/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal and adjacent sites disorders NEC (excl infections and neoplasms)
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion and inflammations
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Nasal disorders NEC
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Parenchymal lung disorders NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal disorders (excl infections and neoplasms)
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax and pleural effusions NEC
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedemas
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract disorders NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract signs and symptoms
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
13.0%
3/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Acnes
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Alopecias
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Apocrine and eccrine gland disorders
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
21.7%
5/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Dermal and epidermal conditions NEC
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Dermatitis and eczema
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Erythemas
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Exfoliative conditions
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Nail and nail bed conditions (excl infections and infestations)
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Pilar disorders NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Purpura and related conditions
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
16.7%
1/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rashes, eruptions and exanthems NEC
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
21.7%
5/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
16.7%
1/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue ulcerations
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Skin injuries and mechanical dermatoses
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Skin preneoplastic conditions NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Surgical and medical procedures
Lens therapeutic procedures
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Vascular disorders
Haemorrhages NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
13.0%
3/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Vascular disorders
Lymphoedemas
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Vascular disorders
Peripheral embolism and thrombosis
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Vascular disorders
Peripheral vascular disorders NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Vascular disorders
Phlebitis NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Vascular disorders
Vascular hypertensive disorders NEC
|
100.0%
4/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Vascular disorders
Vascular hypotensive disorders
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Ear infections
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Eye and eyelid infections
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Female reproductive tract infections
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Herpes viral infections
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Anaemias NEC
|
100.0%
4/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
100.0%
3/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
75.0%
3/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
21.7%
5/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Bleeding tendencies
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Eosinophilic disorders
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Leukocytoses NEC
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Lymphatic system disorders NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
16.7%
1/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Neutropenias
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Thrombocytopenias
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Cardiac disorders
Aortic valvular disorders
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Cardiac disorders
Cardiac conduction disorders
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Cardiac disorders
Cardiac signs and symptoms NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Cardiac disorders
Pericardial disorders NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Cardiac disorders
Supraventricular arrhythmias
|
75.0%
3/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Ear and labyrinth disorders
Ear disorders NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Ear and labyrinth disorders
External ear disorders NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Eye disorders
Choroid and vitreous structural change, deposit and degeneration
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Eye disorders
Lacrimation disorders
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Eye disorders
Ocular bleeding and vascular disorders NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Eye disorders
Ocular disorders NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Eye disorders
Ocular sensation disorders
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Eye disorders
Pupil disorders
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Eye disorders
Visual disorders NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
21.7%
5/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
16.7%
1/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
100.0%
3/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Colitis (excl infective)
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Dental and periodontal infections and inflammations
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea (excl infective)
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
100.0%
3/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
100.0%
4/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
47.8%
11/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
3/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Dyspeptic signs and symptoms
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
13.0%
3/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Flatulence, bloating and distension
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastrointestinal and abdominal pains (excl oral and throat)
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
26.1%
6/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
75.0%
3/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastrointestinal atonic and hypomotility disorders NEC
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastrointestinal inflammatory disorders NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastrointestinal signs and symptoms NEC
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
13.0%
3/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastrointestinal spastic and hypermotility disorders
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Haemorrhoids and gastrointestinal varices (excl oesophageal)
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Nausea and vomiting symptoms
|
100.0%
4/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
100.0%
3/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
75.0%
3/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
73.9%
17/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
2/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
100.0%
3/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
100.0%
4/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Oral dryness and saliva altered
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
17.4%
4/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Oral soft tissue pain and paraesthesia
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Peritoneal and retroperitoneal disorders
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Stomatitis and ulceration
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Tongue signs and symptoms
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Asthenic conditions
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
100.0%
3/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
75.0%
3/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
47.8%
11/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
16.7%
1/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
75.0%
3/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Febrile disorders
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Feelings and sensations NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Gait disturbances
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
General disorders
General signs and symptoms NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Healing abnormal NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Implant and catheter site reactions
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Infusion site reactions
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Mucosal findings abnormal
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Oedema NEC
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
17.4%
4/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
75.0%
3/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Pain and discomfort NEC
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Hepatobiliary disorders
Cholecystitis and cholelithiasis
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Immune system disorders
Allergic conditions NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Immune system disorders
Immunodeficiency disorders NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Abdominal and gastrointestinal infections
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
16.7%
1/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Bacterial infections NEC
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Candida infections
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Clostridia infections
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Dental and oral soft tissue infections
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Infections NEC
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Lower respiratory tract and lung infections
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
13.0%
3/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Skin structures and soft tissue infections
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Upper respiratory tract infections
|
75.0%
3/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
21.7%
5/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Urinary tract infections
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Viral infections NEC
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
16.7%
1/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Non-site specific injuries NEC
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
17.4%
4/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
16.7%
1/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Non-site specific procedural complications
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Overdoses NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Radiation injuries
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Site specific injuries NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Skin injuries NEC
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
21.7%
5/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
2/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Spinal fractures and dislocations
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Thermal burns
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Vaccination related complications
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Investigations
Carbohydrate tolerance analyses (incl diabetes)
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Investigations
Coagulation and bleeding analyses
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Investigations
ECG investigations
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
13.0%
3/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Investigations
Liver function analyses
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Investigations
Mineral and electrolyte analyses
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Investigations
Physical examination procedures and organ system status
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
21.7%
5/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Investigations
Platelet analyses
|
100.0%
4/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
17.4%
4/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
16.7%
1/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Investigations
Renal function analyses
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Investigations
Skeletal and cardiac muscle analyses
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Investigations
Tissue enzyme analyses NEC
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Investigations
White blood cell analyses
|
100.0%
4/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
100.0%
4/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
26.1%
6/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
16.7%
1/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Appetite disorders
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
39.1%
9/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
2/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Calcium metabolism disorders
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
75.0%
3/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
13.0%
3/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Disorders of purine metabolism
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Electrolyte imbalance NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
General nutritional disorders NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hyperglycaemic conditions NEC
|
100.0%
4/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
75.0%
3/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hypoglycaemic conditions NEC
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Magnesium metabolism disorders
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
16.7%
1/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Metabolic alkaloses
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Phosphorus metabolism disorders
|
75.0%
3/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Potassium imbalance
|
75.0%
3/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
16.7%
1/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Protein metabolism disorders NEC
|
100.0%
4/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Sodium imbalance
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
100.0%
3/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
75.0%
3/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Total fluid volume decreased
|
50.0%
2/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
75.0%
3/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Total fluid volume increased
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Water soluble vitamin deficiencies
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthropathies NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
25.0%
1/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Bone disorders NEC
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Bone related signs and symptoms
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Bursal disorders
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/6 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
0.00%
0/4 • For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place