Trial Outcomes & Findings for A Safety and Efficacy Study Evaluating CTX110 in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON) (NCT NCT04035434)
NCT ID: NCT04035434
Last Updated: 2025-10-24
Results Overview
A DLT is defined as any of the following events occurring during the DLT evaluation period that persisted beyond the specified duration from onset: Grade ≥2 graft-versus-host disease (GvHD) that was steroid-refractory (e.g., progressive disease after 3 days of steroid treatment \[e.g., 1 mg/kg/day\], stable disease after 7 days, or partial response after 14 days of treatment); death during the DLT period, unless due to disease progression; Grade 4 neurotoxicity of any duration that was related or possibly related to CTX110; or any CTX110-related grade 3 or 4 toxicity deemed clinically significant by the investigator that did not improve within 72 hours.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
93 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2025-10-24
Participant Flow
The study comprises 4 cohorts: Cohorts A, B, and C enrolled adult participants with non-Hodgkin lymphoma (NHL); Cohort D enrolled participants with adult B cell acute lymphoblastic leukemia (ALL). A total of 93 participants were enrolled; 3 participants died prior to receiving CTX110 (1 due to pulmonary haemorrhage that occurred after lymphodepleting \[LD\] chemotherapy but was assessed as not related to LD chemotherapy, and 2 due to disease progression).
The study was designed to be divided into 2 phases. A total of 8 participants were enrolled in the Phase 2 dose expansion. Due to a high proportion of non-quantifiable values, the secondary efficacy endpoints for Phase 2 participants could not be calculated. The study was terminated early in Phase 2 at the sponsor's discretion.
Participant milestones
| Measure |
Phase 1: NHL: Cohort A: Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10\^7 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
|
Phase 2: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
|
Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells)
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3x10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells)
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase (Up to 5 Years)
STARTED
|
3
|
3
|
6
|
6
|
10
|
4
|
0
|
1
|
5
|
5
|
4
|
5
|
7
|
|
Dose Escalation Phase (Up to 5 Years)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Phase (Up to 5 Years)
NOT COMPLETED
|
3
|
3
|
6
|
6
|
10
|
4
|
0
|
1
|
5
|
5
|
4
|
5
|
7
|
|
Dose Expansion Phase (Up to 5 Years)
STARTED
|
0
|
0
|
0
|
0
|
0
|
23
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion Phase (Up to 5 Years)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion Phase (Up to 5 Years)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
23
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase 1: NHL: Cohort A: Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10\^7 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
|
Phase 2: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
|
Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells)
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3x10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells)
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase (Up to 5 Years)
Withdrawal by Subject
|
0
|
1
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Dose Escalation Phase (Up to 5 Years)
Death
|
3
|
1
|
4
|
3
|
8
|
3
|
0
|
1
|
3
|
4
|
3
|
2
|
1
|
|
Dose Escalation Phase (Up to 5 Years)
Study terminated by the Sponsor
|
0
|
1
|
2
|
0
|
1
|
1
|
0
|
0
|
2
|
1
|
0
|
2
|
6
|
|
Dose Escalation Phase (Up to 5 Years)
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion Phase (Up to 5 Years)
Death
|
0
|
0
|
0
|
0
|
0
|
14
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion Phase (Up to 5 Years)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion Phase (Up to 5 Years)
Study terminated by the Sponsor
|
0
|
0
|
0
|
0
|
0
|
8
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Safety and Efficacy Study Evaluating CTX110 in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON)
Baseline characteristics by cohort
| Measure |
Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
n=3 Participants
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10\^7 CAR+ T cells.
|
Cohort A: DL 2 (1x10^8 CAR+ T Cells)
n=3 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Cohort A: DL 3 (3x10^8 CAR+ T Cells)
n=6 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Cohort A: DL 3b (4.5x10^8 CAR+ T Cells)
n=6 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10\^8 CAR+ T cells.
|
Cohort A: DL 4a (6x10^8 CAR+ T Cells)
n=10 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Cohort A: DL 4b (6x10^8 CAR+ T Cells)
n=35 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
|
Cohort B: DL 4 (6x10^8 CAR+ T Cells)
n=1 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Cohort C: DL 3 (3x10^8 CAR+ T Cells)
n=5 Participants
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3x10\^8 CAR+ T cells.
|
Cohort C: DL 4 (6x10^8 CAR+ T Cells)
n=5 Participants
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
n=4 Participants
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
n=5 Participants
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
n=7 Participants
Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.3 Years
STANDARD_DEVIATION 5.86 • n=5 Participants
|
65.3 Years
STANDARD_DEVIATION 8.08 • n=7 Participants
|
68.2 Years
STANDARD_DEVIATION 5.34 • n=5 Participants
|
61.5 Years
STANDARD_DEVIATION 18.29 • n=4 Participants
|
61.8 Years
STANDARD_DEVIATION 10.90 • n=21 Participants
|
64.0 Years
STANDARD_DEVIATION 11.74 • n=10 Participants
|
59.0 Years
STANDARD_DEVIATION NA • n=115 Participants
|
71.0 Years
STANDARD_DEVIATION 8.43 • n=24 Participants
|
63.8 Years
STANDARD_DEVIATION 6.65 • n=42 Participants
|
35.0 Years
STANDARD_DEVIATION 10.30 • n=42 Participants
|
39.4 Years
STANDARD_DEVIATION 13.83 • n=42 Participants
|
47.7 Years
STANDARD_DEVIATION 17.61 • n=42 Participants
|
60.0 Years
STANDARD_DEVIATION 14.50 • n=36 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
29 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
61 Participants
n=36 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=10 Participants
|
0 Participants
n=115 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
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=36 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=10 Participants
|
0 Participants
n=115 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
|
0 Participants
n=36 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
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 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
|
4 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
75 Participants
n=36 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=10 Participants
|
0 Participants
n=115 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
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: DLT Evaluable Set comprised of participants who received CTX110 and are followed for at least 28 days post-infusion or withdraw consent after experiencing a DLT.
A DLT is defined as any of the following events occurring during the DLT evaluation period that persisted beyond the specified duration from onset: Grade ≥2 graft-versus-host disease (GvHD) that was steroid-refractory (e.g., progressive disease after 3 days of steroid treatment \[e.g., 1 mg/kg/day\], stable disease after 7 days, or partial response after 14 days of treatment); death during the DLT period, unless due to disease progression; Grade 4 neurotoxicity of any duration that was related or possibly related to CTX110; or any CTX110-related grade 3 or 4 toxicity deemed clinically significant by the investigator that did not improve within 72 hours.
Outcome measures
| Measure |
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
n=3 Participants
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10\^7 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells)
n=3 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells)
n=6 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells)
n=6 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells)
n=10 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells)
n=4 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
|
Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells)
n=1 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells)
n=5 Participants
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3\*10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells)
n=5 Participants
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
n=4 Participants
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
n=5 Participants
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
n=7 Participants
Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase 1: Number of Participants With Dose-limiting Toxicities (DLT) in NHL and B Cell ALL Population
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Full Analysis Set comprised of participants who received CTX110 infusion have baseline and at least 1 post-baseline disease assessment.
The objective response rate (complete response + partial response) was analyzed as per Lugano Response Criteria for Malignant Lymphoma, as determined by independent central radiology review. For participants who received the second course of treatment, the response assessments before and after the second course are combined for the derivation of objective response. Percentages are calculated with the number of participants in the specific analysis set in each column as the denominator. Confidence intervals (CI) of percentage are calculated with Clopper-Pearson exact method.
Outcome measures
| Measure |
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
n=23 Participants
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10\^7 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells)
n=8 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
|
Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells)
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3\*10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells)
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Phase 1 and Phase 2: Percentage of Participants With Objective Response Rate in NHL Population
|
60.9 Percentage of participants
Interval 38.5 to 80.3
|
75.0 Percentage of participants
Interval 34.9 to 96.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Full Analysis Set comprised of participants who received CTX110 infusion have baseline and at least 1 post-baseline disease assessment.
The objective response rate (complete response + complete remission with incomplete blood count recovery) was analyzed as per response criteria adapted from the National Comprehensive Cancer Network guidelines for treatment of acute lymphoblastic leukemia Version 2.2021, as determined by independent central radiology review. For -participants who receive the second course of treatment, the response assessments before and after the second course are combined for the derivation of objective response. Percentages are calculated with the number of participants in the specific analysis set in each column as the denominator. Confidence intervals (CI) of percentage are calculated with Clopper-Pearson exact method.
Outcome measures
| Measure |
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
n=4 Participants
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10\^7 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells)
n=5 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells)
n=7 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
|
Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells)
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3\*10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells)
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase 1: Percentage of Participants With Objective Response Rate in B Cell ALL Population
|
25.0 Percentage of Participants
Interval 0.6 to 80.6
|
40.0 Percentage of Participants
Interval 5.3 to 85.3
|
85.7 Percentage of Participants
Interval 42.1 to 99.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Full Analysis Set: Participants who reported objective response events were analyzed. The duration of response for Phase 2 could not be calculated due to the high proportion of non-quantifiable values.
Duration of response was only reported for the participants who showed objective response events. This was calculated as the time between first objective response and date of disease progression or death due to any cause. Median duration of response was calculated with the Kaplan-Meier method. Confidence intervals of median duration of response were calculated with the Brookmeyer and Crowley method with log-log transformation.
Outcome measures
| Measure |
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10\^7 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells)
n=1 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells)
n=4 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells)
n=4 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells)
n=7 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells)
n=16 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
|
Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells)
n=1 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells)
n=3 Participants
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3\*10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells)
n=2 Participants
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Phase 1: Duration of Response in NHL Population
|
—
|
9.20 Months
Due to smaller number of events, 95% CI could not be calculated.
|
3.75 Months
Interval 1.68 to
Due to smaller number of events, upper 95% CI could not be calculated.
|
3.52 Months
Interval 0.95 to
Due to smaller number of events, upper 95% CI could not be calculated.
|
1.02 Months
Interval 0.46 to 1.31
|
3.60 Months
Interval 1.91 to 8.57
|
NA Months
NA indicates single participant did not allow meaningful calculation of median and its 95% CI.
|
2.20 Months
Interval 2.0 to
Due to smaller number of events, upper 95% CI could not be calculated.
|
1.56 Months
Interval 1.05 to
Due to smaller number of events, upper 95% CI could not be calculated.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Full Analysis Set: Participants who reported PFS events were analyzed. The progression free survival for Phase 2 could not be calculated due to the high proportion of non-quantifiable values.
Progression-free survival (PFS) and event-free survival were calculated as the difference between date of CTX110 infusion and date of disease progression or death due to any cause. The median of PFS was calculated with the Kaplan-Meier method. The CIs of median PFS were calculated with the Brookmeyer and Crowley method with log-log transformation.
Outcome measures
| Measure |
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
n=3 Participants
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10\^7 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells)
n=3 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells)
n=6 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells)
n=6 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells)
n=10 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells)
n=27 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
|
Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells)
n=1 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells)
n=5 Participants
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3\*10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells)
n=5 Participants
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Phase 1: Progression Free Survival (PFS) in NHL Population
|
0.92 Months
Interval 0.79 to
Due to smaller number of events, upper 95% CI could not be calculated.
|
1.91 Months
Interval 0.85 to
Due to smaller number of events, upper 95% CI could not be calculated.
|
2.43 Months
Interval 0.95 to
Due to smaller number of events, upper 95% CI could not be calculated.
|
1.54 Months
Interval 0.82 to
Due to smaller number of events, upper 95% CI could not be calculated.
|
1.77 Months
Interval 0.76 to 2.1
|
2.83 Months
Interval 1.02 to 3.94
|
NA Months
NA indicates single participant did not allow meaningful calculation of median and its 95% CI.
|
2.92 Months
Interval 0.79 to
Due to smaller number of events, upper 95% CI could not be calculated.
|
1.94 Months
Interval 0.92 to
Due to smaller number of events, upper 95% CI could not be calculated.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Full Analysis Set: Participants reporting overall survival rate were analyzed. The median overall survival for Phase 2 could not be calculated due to the high proportion of non-quantifiable values.
Overall survival was calculated as the time between date of first dose of CTX110 and death due to any cause. Participants who are alive at the data cutoff date will be censored at their last date known to be alive. Median overall survival was calculated with the Kaplan-Meier method. CIs of median overall survival were calculated with the Brookmeyer and Crowley method with log-log transformation.
Outcome measures
| Measure |
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
n=3 Participants
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10\^7 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells)
n=3 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells)
n=6 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells)
n=6 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells)
n=10 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells)
n=27 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
|
Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells)
n=1 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells)
n=5 Participants
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3\*10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells)
n=5 Participants
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Phase 1: Median Overall Survival (OS) in NHL Population
|
5.03 Months
Interval 2.73 to
Due to smaller number of events, upper 95% CI could not be calculated.
|
37.16 Months
Interval 1.05 to
Due to smaller number of events, upper 95% CI could not be calculated.
|
7.77 Months
Interval 2.96 to
Due to smaller number of events, upper 95% CI could not be calculated.
|
NA Months
Interval 1.61 to
Due to smaller number of events, the median and upper 95% CI could not be calculated.
|
5.16 Months
Interval 1.71 to 27.73
|
14.26 Months
Interval 4.47 to
Due to smaller number of events, upper 95% CI could not be calculated.
|
12.12 Months
Due to smaller number of events, 95% CI could not be calculated.
|
7.39 Months
Interval 1.18 to
Due to smaller number of events, upper 95% CI could not be calculated.
|
7.62 Months
Interval 1.71 to
Due to smaller number of events, upper 95% CI could not be calculated.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Safety Analysis Set. The safety data are presented by treatment received and not by study phase.
A TEAE was any untoward medical occurrence or worsening of a pre-existing condition in a clinical trial participant who received the investigational medicinal product, regardless of a causal relationship with the treatment. An AE had to be classified as a serious adverse event (SAE) if it resulted in death, was life-threatening, required or prolonged hospitalization, caused persistent or significant disability or incapacity, led to a congenital anomaly or birth defect in a newborn, or was deemed a significant medical event by the investigator based on medical judgment.
Outcome measures
| Measure |
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
n=3 Participants
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10\^7 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells)
n=3 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells)
n=6 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells)
n=6 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells)
n=10 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells)
n=35 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
|
Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells)
n=1 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells)
n=5 Participants
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3\*10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells)
n=5 Participants
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
n=4 Participants
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
n=5 Participants
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
n=7 Participants
Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion: Number of Participants With Treatment Emergent Adverse Events (TEAEs) in NHL and B Cell ALL Population
|
3 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
10 Participants
|
34 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Safety Analysis Set. The safety data are presented by treatment received and not by study phase.
Blood samples were collected for the analysis of laboratory parameters including hematology, clinical chemistry and coagulation parameters. The hematology parameters included: Lymphocyte count decreased, Neutrophil count decreased, White blood cell decreased, Anemia, Platelet count decreased, leukocytosis and Lymphocyte count increased. Chemistry parameters included: Hypoalbuminemia, Aspartate aminotransferase increased, Alanine aminotransferase increased, Hypokalemia, Chronic kidney disease, Blood bilirubin increased, Creatinine increased, Hypermagnesemia, Hypernatremia, Hypercalcemia, Hyperkalemia, and Hypoglycemia. Coagulation parameters included: Activated partial thromboplastin time prolonged, Fibrinogen decreased, and INR increased. Grade 3 and above severity of laboratory abnormalities are considered as clinically significant laboratory abnormalities.
Outcome measures
| Measure |
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
n=3 Participants
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10\^7 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells)
n=3 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells)
n=6 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells)
n=6 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells)
n=10 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells)
n=35 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
|
Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells)
n=1 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells)
n=5 Participants
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3\*10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells)
n=5 Participants
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
n=4 Participants
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
n=5 Participants
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
n=7 Participants
Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Neutrophil count decreased
|
3 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
10 Participants
|
35 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
|
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
White blood cell decreased
|
3 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
10 Participants
|
35 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
|
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Lymphocyte count decreased
|
3 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
10 Participants
|
35 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
|
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Anemia
|
1 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
8 Participants
|
17 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Platelet count decreased
|
1 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
6 Participants
|
19 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Lymphocyte count increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Hypoalbuminemia
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Aspartate aminotransferase increased
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Alanine aminotransferase increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Hypokalemia
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Hypercalcemia
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Hypermagnesemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Hyperkalemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Hypoglycemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Chronic kidney disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Blood bilirubin increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Creatinine increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Hypernatremia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Activated partial thromboplastin time prolonged
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Fibrinogen decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
INR increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Dose Escalation and Expansion: Number of Participants With Clinically Significant Laboratory Abnormalities in NHL and B Cell ALL Population
Leukocytosis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 pre-infusion, Day 1 post-infusion, Day 2, Day 3, Day 5, Day 8, Day 10, Day 14, Day 21, Day 28, Month 2, Month 3, Month 6, Month 9, Month 12 and Month 24Population: Full Analysis Set. Only those participants with data available at specified timepoints has been presented.
Blood samples were collected for the analysis of mean concentration of CTX110 in blood (copies per micrograms deoxyribose nucleic acid \[DNA\]) over time following the first CTX110 infusion. Cohort A DL4a and DL4b were combined, as the same dose was administered. Mean concentration values of CTX110 have been presented by dose level.
Outcome measures
| Measure |
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
n=6 Participants
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10\^7 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells)
n=6 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells)
n=1 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells)
n=5 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells)
n=5 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells)
n=45 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
|
Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells)
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3\*10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells)
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population
Day 28
|
4.00 Copies per micrograms DNA
Standard Deviation 2.452
|
2.90 Copies per micrograms DNA
Standard Deviation 0.000
|
2.90 Copies per micrograms DNA
Standard Deviation NA
The standard deviation cannot be calculated for single participant
|
6.67 Copies per micrograms DNA
Standard Deviation 8.437
|
2.90 Copies per micrograms DNA
Standard Deviation NA
The standard deviation cannot be calculated for single participant
|
8.32 Copies per micrograms DNA
Standard Deviation 28.058
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population
Month 2
|
3.88 Copies per micrograms DNA
Standard Deviation 1.379
|
2.90 Copies per micrograms DNA
Standard Deviation 0.000
|
NA Copies per micrograms DNA
Standard Deviation NA
Mean and standard deviation could not be calculated as all concentration values were below the lower limit of quantification
|
11.17 Copies per micrograms DNA
Standard Deviation 14.318
|
2.90 Copies per micrograms DNA
Standard Deviation NA
The standard deviation cannot be calculated for single participant
|
2.90 Copies per micrograms DNA
Standard Deviation 0.000
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population
Month 3
|
3.55 Copies per micrograms DNA
Standard Deviation 1.126
|
2.90 Copies per micrograms DNA
Standard Deviation 0.000
|
NA Copies per micrograms DNA
Standard Deviation NA
Mean and standard deviation could not be calculated as all concentration values were below the lower limit of quantification
|
2.90 Copies per micrograms DNA
Standard Deviation 0.000
|
2.90 Copies per micrograms DNA
Standard Deviation NA
The standard deviation cannot be calculated for single participant
|
2.90 Copies per micrograms DNA
Standard Deviation NA
The standard deviation cannot be calculated for single participant
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population
Month 6
|
2.90 Copies per micrograms DNA
Standard Deviation 0.000
|
2.90 Copies per micrograms DNA
Standard Deviation NA
The standard deviation cannot be calculated for single participant
|
NA Copies per micrograms DNA
Standard Deviation NA
Mean and standard deviation could not be calculated as all concentration values were below the lower limit of quantification
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population
Month 9
|
—
|
2.90 Copies per micrograms DNA
Standard Deviation NA
The standard deviation cannot be calculated for single participant
|
NA Copies per micrograms DNA
Standard Deviation NA
Mean and standard deviation could not be calculated as all concentration values were below the lower limit of quantification
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population
Day 1 pre-infusion
|
2.90 Copies per micrograms DNA
Standard Deviation 0.000
|
3.55 Copies per micrograms DNA
Standard Deviation 1.592
|
2.90 Copies per micrograms DNA
Standard Deviation NA
The standard deviation cannot be calculated for single participant
|
2.90 Copies per micrograms DNA
Standard Deviation 0.000
|
2.90 Copies per micrograms DNA
Standard Deviation 0.000
|
3.08 Copies per micrograms DNA
Standard Deviation 0.934
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population
Day 1 post-infusion
|
144.95 Copies per micrograms DNA
Standard Deviation 147.856
|
829.37 Copies per micrograms DNA
Standard Deviation 1552.483
|
472.20 Copies per micrograms DNA
Standard Deviation NA
The standard deviation cannot be calculated for single participant
|
105.22 Copies per micrograms DNA
Standard Deviation 23.028
|
636.29 Copies per micrograms DNA
Standard Deviation 352.700
|
979.25 Copies per micrograms DNA
Standard Deviation 1658.499
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population
Day 2
|
7.27 Copies per micrograms DNA
Standard Deviation 6.403
|
10.77 Copies per micrograms DNA
Standard Deviation 13.999
|
28.57 Copies per micrograms DNA
Standard Deviation NA
The standard deviation cannot be calculated for single participant
|
35.62 Copies per micrograms DNA
Standard Deviation 22.359
|
72.39 Copies per micrograms DNA
Standard Deviation 107.323
|
42.39 Copies per micrograms DNA
Standard Deviation 101.461
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population
Day 3
|
8.36 Copies per micrograms DNA
Standard Deviation 5.310
|
12.46 Copies per micrograms DNA
Standard Deviation 9.656
|
22.03 Copies per micrograms DNA
Standard Deviation NA
The standard deviation cannot be calculated for single participant
|
16.76 Copies per micrograms DNA
Standard Deviation 13.050
|
204.43 Copies per micrograms DNA
Standard Deviation 300.219
|
35.80 Copies per micrograms DNA
Standard Deviation 98.739
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population
Day 5
|
25.47 Copies per micrograms DNA
Standard Deviation 21.898
|
220.78 Copies per micrograms DNA
Standard Deviation 246.411
|
311.67 Copies per micrograms DNA
Standard Deviation NA
The standard deviation cannot be calculated for single participant
|
80.40 Copies per micrograms DNA
Standard Deviation 33.878
|
487.13 Copies per micrograms DNA
Standard Deviation 262.303
|
770.14 Copies per micrograms DNA
Standard Deviation 3312.713
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population
Day 8
|
3763.68 Copies per micrograms DNA
Standard Deviation 8138.642
|
4337.42 Copies per micrograms DNA
Standard Deviation 7721.088
|
13269.43 Copies per micrograms DNA
Standard Deviation NA
The standard deviation cannot be calculated for single participant
|
5844.98 Copies per micrograms DNA
Standard Deviation 9600.631
|
719.13 Copies per micrograms DNA
Standard Deviation 231.318
|
10277.87 Copies per micrograms DNA
Standard Deviation 27526.126
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population
Day 10
|
180.87 Copies per micrograms DNA
Standard Deviation 209.131
|
452.03 Copies per micrograms DNA
Standard Deviation 941.853
|
25719.13 Copies per micrograms DNA
Standard Deviation NA
The standard deviation cannot be calculated for single participant
|
19018.53 Copies per micrograms DNA
Standard Deviation 42303.294
|
297.91 Copies per micrograms DNA
Standard Deviation 248.623
|
4056.03 Copies per micrograms DNA
Standard Deviation 19737.607
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population
Day 14
|
2.90 Copies per micrograms DNA
Standard Deviation 0.000
|
3.55 Copies per micrograms DNA
Standard Deviation 1.592
|
9.93 Copies per micrograms DNA
Standard Deviation NA
The standard deviation cannot be calculated for single participant
|
2435.23 Copies per micrograms DNA
Standard Deviation 5423.525
|
51.73 Copies per micrograms DNA
Standard Deviation 87.882
|
2186.81 Copies per micrograms DNA
Standard Deviation 13766.282
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population
Day 21
|
2.90 Copies per micrograms DNA
Standard Deviation 0.000
|
2.90 Copies per micrograms DNA
Standard Deviation 0.000
|
2.90 Copies per micrograms DNA
Standard Deviation NA
The standard deviation cannot be calculated for single participant
|
64.48 Copies per micrograms DNA
Standard Deviation 123.167
|
3.88 Copies per micrograms DNA
Standard Deviation 1.950
|
2537.64 Copies per micrograms DNA
Standard Deviation 11074.754
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population
Month 12
|
—
|
2.90 Copies per micrograms DNA
Standard Deviation NA
The standard deviation cannot be calculated for single participant
|
NA Copies per micrograms DNA
Standard Deviation NA
Mean and standard deviation could not be calculated as all concentration values were below the lower limit of quantification
|
2.90 Copies per micrograms DNA
Standard Deviation NA
The standard deviation cannot be calculated for single participant
|
2.90 Copies per micrograms DNA
Standard Deviation NA
The standard deviation cannot be calculated for single participant
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in NHL Population
Month 24
|
—
|
2.90 Copies per micrograms DNA
Standard Deviation NA
The standard deviation cannot be calculated for single participant
|
NA Copies per micrograms DNA
Standard Deviation NA
Mean and standard deviation could not be calculated as all concentration values were below the lower limit of quantification
|
NA Copies per micrograms DNA
Standard Deviation NA
Mean and standard deviation could not be calculated as all concentration values were below the lower limit of quantification
|
NA Copies per micrograms DNA
Standard Deviation NA
Mean and standard deviation could not be calculated as all concentration values were below the lower limit of quantification
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-infusion, Day 1 post-infusion, Day 2, Day 3, Day 5, Day 8, Day 10, Day 14, Day 21, Day 28, and Month 2Population: Full Analysis Set
Blood samples were collected for the analysis of mean concentration of CTX110 in blood (copies per micrograms deoxyribose nucleic acid \[DNA\]) over time following the first CTX110 infusion.
Outcome measures
| Measure |
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
n=4 Participants
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10\^7 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells)
n=5 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells)
n=7 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
|
Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells)
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells)
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3\*10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells)
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population
Day 1 pre-infusion
|
13.43 Copies per micrograms DNA
Standard Deviation 21.067
|
3.29 Copies per micrograms DNA
Standard Deviation 0.872
|
2.90 Copies per micrograms DNA
Standard Deviation 0.000
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population
Day 1 post-infusion
|
781.86 Copies per micrograms DNA
Standard Deviation 1395.907
|
1983.57 Copies per micrograms DNA
Standard Deviation 1677.746
|
602.75 Copies per micrograms DNA
Standard Deviation 521.357
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population
Day 2
|
4.20 Copies per micrograms DNA
Standard Deviation 2.252
|
93.47 Copies per micrograms DNA
Standard Deviation 149.220
|
18.13 Copies per micrograms DNA
Standard Deviation 17.532
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population
Day 3
|
13.46 Copies per micrograms DNA
Standard Deviation 14.905
|
20.47 Copies per micrograms DNA
Standard Deviation 25.356
|
7.95 Copies per micrograms DNA
Standard Deviation 4.705
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population
Day 5
|
28.65 Copies per micrograms DNA
Standard Deviation 36.011
|
42.37 Copies per micrograms DNA
Standard Deviation 47.444
|
62.85 Copies per micrograms DNA
Standard Deviation 124.743
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population
Day 8
|
71.30 Copies per micrograms DNA
Standard Deviation 118.215
|
16846.17 Copies per micrograms DNA
Standard Deviation 33459.507
|
15941.89 Copies per micrograms DNA
Standard Deviation 30200.959
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population
Day 10
|
226.32 Copies per micrograms DNA
Standard Deviation 290.508
|
26.17 Copies per micrograms DNA
Standard Deviation 41.517
|
14177.59 Copies per micrograms DNA
Standard Deviation 23256.089
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population
Day 14
|
1040.13 Copies per micrograms DNA
Standard Deviation 1466.869
|
2.90 Copies per micrograms DNA
Standard Deviation 0.000
|
380.29 Copies per micrograms DNA
Standard Deviation 924.424
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population
Day 21
|
3.55 Copies per micrograms DNA
Standard Deviation 1.126
|
2.90 Copies per micrograms DNA
Standard Deviation 0.000
|
2.90 Copies per micrograms DNA
Standard Deviation 0.000
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population
Day 28
|
2.90 Copies per micrograms DNA
Standard Deviation 0.000
|
2.90 Copies per micrograms DNA
Standard Deviation 0.000
|
2.90 Copies per micrograms DNA
Standard Deviation 0.000
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion Phase 1: Mean Concentration of CTX110 in Blood Over Time Following the First CTX110 Infusion in B Cell ALL Population
Month 2
|
2.90 Copies per micrograms DNA
Standard Deviation NA
The standard deviation cannot be calculated for single participant
|
2.90 Copies per micrograms DNA
Standard Deviation NA
The standard deviation cannot be calculated for single participant
|
2.90 Copies per micrograms DNA
Standard Deviation NA
The standard deviation cannot be calculated for single participant
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Safety Analysis Set. The safety data are presented by treatment received and not by study phase.
An AE had to be classified as a serious adverse event (SAE) if it resulted in death, was life-threatening, required or prolonged hospitalization, caused persistent or significant disability or incapacity, led to a congenital anomaly or birth defect in a newborn, or was deemed a significant medical event by the investigator based on medical judgment.
Outcome measures
| Measure |
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
n=3 Participants
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10\^7 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells)
n=3 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells)
n=6 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells)
n=6 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells)
n=10 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells)
n=35 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
|
Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells)
n=1 Participants
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells)
n=5 Participants
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3\*10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells)
n=5 Participants
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
n=4 Participants
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
n=5 Participants
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
n=7 Participants
Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion: Number of Participants With Serious Adverse Events (SAEs) in NHL and B Cell ALL Population
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
8 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
Adverse Events
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 4 deaths
Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 3 deaths
Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells)
Serious events: 5 serious events
Other events: 10 other events
Deaths: 9 deaths
Phase 1/2: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells)
Serious events: 8 serious events
Other events: 34 other events
Deaths: 21 deaths
Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 3 deaths
Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells)
Serious events: 4 serious events
Other events: 5 other events
Deaths: 4 deaths
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
Serious events: 3 serious events
Other events: 5 other events
Deaths: 2 deaths
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
n=3 participants at risk
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10\^7 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells)
n=3 participants at risk
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells)
n=6 participants at risk
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells)
n=6 participants at risk
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells)
n=10 participants at risk
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1/2: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells)
n=35 participants at risk
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
|
Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells)
n=1 participants at risk
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells)
n=5 participants at risk
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3x10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells)
n=5 participants at risk
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
n=4 participants at risk
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
n=5 participants at risk
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
n=7 participants at risk
B Cell ALL: Cohort D: DL 4 (6\*10\^8 CAR+ T Cells) Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
8.6%
3/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Nervous system disorders
Immune effector cell-associated neurotoxicity syndrome
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
2/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
General disorders
Pain
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
30.0%
3/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
8.6%
3/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
40.0%
2/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Renal and urinary disorders
Renal vein thrombosis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
25.0%
1/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Periorbital cellulitis
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
25.0%
1/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
25.0%
1/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
25.0%
1/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
General disorders
Death
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
Other adverse events
| Measure |
Phase 1: NHL: Cohort A Dose Level (DL) 1 (3×10^7 CAR+ T Cells)
n=3 participants at risk
Participants with non-Hodgkin lymphoma (NHL) received lymphodepleting (LD) chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered intravenously (IV) once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3x10\^7 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 2 (1x10^8 CAR+ T Cells)
n=3 participants at risk
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3 (3x10^8 CAR+ T Cells)
n=6 participants at risk
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 3b (4.5x10^8 CAR+ T Cells)
n=6 participants at risk
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 4.5×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort A: DL 4a (6x10^8 CAR+ T Cells)
n=10 participants at risk
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1/2: NHL: Cohort A: DL 4b (6x10^8 CAR+ T Cells)
n=35 participants at risk
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells and includes participants with 2 planned infusions during treatment course 1.
|
Phase 1: NHL: Cohort B: DL 4 (6x10^8 CAR+ T Cells)
n=1 participants at risk
Participants with NHL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (750 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 3 (3x10^8 CAR+ T Cells)
n=5 participants at risk
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 3x10\^8 CAR+ T cells.
|
Phase 1: NHL: Cohort C: DL 4 (6x10^8 CAR+ T Cells)
n=5 participants at risk
Participants with NHL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 2 (1x10^8 CAR+ T Cells)
n=4 participants at risk
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 1x10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 3 (3x10^8 CAR+ T Cells)
n=5 participants at risk
Participants with B Cell ALL received LD chemotherapy consisting of fludarabine (30 mg/m²) and cyclophosphamide (500 mg/m²) administered IV once daily for three consecutive days. LD chemotherapy was completed at least 48 hours, but no more than 7 days, before infusion of CTX110. CTX110 was given as a single IV infusion of 3×10\^8 CAR+ T cells.
|
Phase 1: B Cell ALL: Cohort D: DL 4 (6x10^8 CAR+ T Cells)
n=7 participants at risk
B Cell ALL: Cohort D: DL 4 (6\*10\^8 CAR+ T Cells) Participants with B Cell ALL received daratumumab (16 mg/kg) at least 1 day before LD chemotherapy and within 10 days prior to CTX110 infusion. LD chemotherapy (fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² IV daily for 3 days) was completed 48 hours to 7 days before CTX110 infusion. Participants with stable disease or better on Day 28 received additional daratumumab doses at Day 28 (±4 days) and Month 2 (±4 days). CTX110 was given as a single IV infusion of 6×10\^8 CAR+ T cells.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
66.7%
2/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
83.3%
5/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
50.0%
3/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
50.0%
5/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
34.3%
12/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
60.0%
3/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
40.0%
2/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
57.1%
4/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
33.3%
2/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
2/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
31.4%
11/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
100.0%
1/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
60.0%
3/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
80.0%
4/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
50.0%
2/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Reproductive system and breast disorders
Genital cyst
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
11.4%
4/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
100.0%
1/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
28.6%
2/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
66.7%
2/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
2/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
40.0%
2/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
25.0%
1/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
40.0%
2/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
28.6%
2/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
30.0%
3/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
25.7%
9/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
25.0%
1/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
57.1%
4/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
5/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
8.6%
3/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
8.6%
3/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
50.0%
2/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
General disorders
Catheter site pain
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
General disorders
Pain
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
General disorders
Chills
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
General disorders
Face oedema
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
General disorders
Feeling abnormal
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Immune system disorders
Cytokine release syndrome
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
33.3%
2/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
40.0%
4/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
45.7%
16/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
100.0%
1/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
40.0%
2/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
60.0%
3/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
71.4%
5/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary cavitation
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
28.6%
2/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Reproductive system and breast disorders
Pleural effusion
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
100.0%
1/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Psychiatric disorders
Hallucination, auditory
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
100.0%
1/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
28.6%
2/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
11.4%
4/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
28.6%
2/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Investigations
Cardiac murmur
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Investigations
Blood potassium increased
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Investigations
Troponin I increased
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Investigations
Weight increased
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
28.6%
2/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
8.6%
3/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
11.4%
4/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
30.0%
3/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
11.4%
4/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
25.0%
1/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
28.6%
2/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Nervous system disorders
Immune effector cell-associated neurotoxicity syndrome
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Blood and lymphatic system disorders
Methaemoglobinaemia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Nervous system disorders
Tremor
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Investigations
Anosmia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Investigations
Dysarthria
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Investigations
Muscle spasticity
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
2/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
66.7%
2/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
83.3%
5/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
50.0%
3/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
80.0%
8/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
57.1%
20/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
40.0%
2/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
80.0%
4/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
25.0%
1/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
60.0%
3/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
85.7%
6/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
50.0%
3/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
50.0%
3/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
70.0%
7/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
45.7%
16/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
60.0%
3/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
42.9%
3/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
25.0%
1/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Eye disorders
Diplopia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Eye disorders
Eye irritation
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
50.0%
3/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
28.6%
10/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
25.0%
1/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
42.9%
3/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
50.0%
3/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
2/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
25.7%
9/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
100.0%
1/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
40.0%
2/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
40.0%
2/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
33.3%
2/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
33.3%
2/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
7/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
40.0%
2/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
40.0%
2/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
25.0%
1/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
28.6%
2/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
40.0%
2/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
28.6%
2/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
40.0%
2/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Hepatobiliary disorders
Hepatic vascular thrombosis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
8.6%
3/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
33.3%
2/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
25.0%
1/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
30.0%
3/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Renal and urinary disorders
Dysuria
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Renal and urinary disorders
Renal vein thrombosis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
11.4%
4/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
40.0%
2/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
40.0%
2/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
40.0%
2/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Pneumonia moraxella
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Viruria
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
100.0%
1/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
2/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
8.6%
3/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
33.3%
1/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
33.3%
2/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
2/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
8.6%
3/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
100.0%
1/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
25.0%
1/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
57.1%
4/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
2/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
8.6%
3/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Metabolism and nutrition disorders
Magnesium deficiency
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
General disorders
Catheter site swelling
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
10.0%
1/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
2.9%
1/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
42.9%
3/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
25.0%
1/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
General disorders
Catheter site thrombosis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Immune system disorders
Graft versus host disease
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
16.7%
1/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
2/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
8.6%
3/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
25.0%
1/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Investigations
Lymph node palpable
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Investigations
Respiratory syncytial virus test positive
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
5.7%
2/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
20.0%
1/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/3 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/6 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/10 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/35 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/1 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/4 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
0.00%
0/5 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
14.3%
1/7 • Up to 5 years
The safety analysis set is comprised of all participants who are enrolled and received study treatment. The participants in the safety analysis set were classified according to the received study treatment. The safety analysis set was the default set for safety analyses.
|
Additional Information
Annie Weaver, PhD: Study Director
CRISPR Therapeutics AG
Phone: +1 617-315-4600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER