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Trial Outcomes & Findings for A Phase II Dose-escalation Study Characterizing the PK of Eltrombopag in Pediatric Patients With Previously Untreated or Relapsed Severe Aplastic Anemia or Recurrent Aplastic Anemia (NCT NCT03025698)

NCT ID: NCT03025698

Last Updated: 2026-08-10

Results Overview

AUC tau: Area under the curve calculated to the end of the dosing interval ( tau) (mass\*time/volume) AUC last: Area under the curve calculated to the last quantifiable concentration point (Tlast) (mass\*time/volume)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

at least 11 weeks after dose initiation or later when patients are taking the highest dose, up to Week 78

Results posted on

2026-08-10

Participant Flow

Study was conducted in 19 sites in 6 countries

Participants participated in a treatment period (26 weeks), follow-up period (additional 52 weeks) and a Long-term Follow-up period for 3 additional years. A dose of 25mg daily for 1 to 6 years and 50 mg daily for 6 to \<18 years was administered. Doses could be modified every two weeks based on blood platelet counts and dosing guidelines until targeted platelet count or maximum dose of 150 mg was achieved, whichever occurred first. .

Participant milestones

Participant milestones
Measure
Cohort A: Regimen 1
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2
Participants received CsA and eltrombopag beginning on Day 1
Cohort B
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Overall Study
STARTED
10
4
37
Overall Study
Participants Who Entered 26-week Treatment Phase
10
4
37
Overall Study
Completed 26-week (Wk) Treatment
7
4
25
Overall Study
Entered 52-wk Post-treatment Follow up Phase 1 (Wk 78)
9
4
26
Overall Study
Did Not Enter 52-wk Post-treatment f/u Phase (Wk 78)
1
0
11
Overall Study
Entered 3-year Post-treatment Follow-up 2
6
3
19
Overall Study
Did Not Complete PTFU2
1
1
9
Overall Study
COMPLETED
5
2
10
Overall Study
NOT COMPLETED
5
2
27

Reasons for withdrawal

Reasons for withdrawal
Measure
Cohort A: Regimen 1
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2
Participants received CsA and eltrombopag beginning on Day 1
Cohort B
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Overall Study
Adverse Event
0
0
2
Overall Study
Physician Decision
3
0
8
Overall Study
Progressive Disease
0
0
3
Overall Study
Participant/Guardian Decision
2
1
11
Overall Study
Lost to Follow-up
0
0
1
Overall Study
Death
0
1
0
Overall Study
Completed study treatment/discontinued study for unspecified reasons
0
0
2

Baseline Characteristics

A Phase II Dose-escalation Study Characterizing the PK of Eltrombopag in Pediatric Patients With Previously Untreated or Relapsed Severe Aplastic Anemia or Recurrent Aplastic Anemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cohort A: Regimen 1
n=10 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2
n=4 Participants
Participants received CsA and eltrombopag beginning on Day 1
Cohort B
n=37 Participants
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Total
n=51 Participants
Total of all reporting groups
Age, Continuous
12.0 Years
n=54 Participants
10.0 Years
n=54 Participants
10.0 Years
n=27 Participants
10.0 Years
n=26 Participants
Sex: Female, Male
Female
5 Participants
n=54 Participants
1 Participants
n=54 Participants
17 Participants
n=27 Participants
23 Participants
n=26 Participants
Sex: Female, Male
Male
5 Participants
n=54 Participants
3 Participants
n=54 Participants
20 Participants
n=27 Participants
28 Participants
n=26 Participants
Race/Ethnicity, Customized
Caucasian
4 Participants
n=54 Participants
2 Participants
n=54 Participants
24 Participants
n=27 Participants
30 Participants
n=26 Participants
Race/Ethnicity, Customized
Black
2 Participants
n=54 Participants
1 Participants
n=54 Participants
4 Participants
n=27 Participants
7 Participants
n=26 Participants
Race/Ethnicity, Customized
Asian
3 Participants
n=54 Participants
1 Participants
n=54 Participants
9 Participants
n=27 Participants
13 Participants
n=26 Participants
Race/Ethnicity, Customized
Unknown
1 Participants
n=54 Participants
0 Participants
n=54 Participants
0 Participants
n=27 Participants
1 Participants
n=26 Participants

PRIMARY outcome

Timeframe: at least 11 weeks after dose initiation or later when patients are taking the highest dose, up to Week 78

Population: The Number of Participants Analyzed reflects the Pharmacokinetic Analysis Set 1 (PAS1), which comprised all participants who provided an evaluable PK profile. For each outcome, the Number Analyzed represents the subset of participants in PAS1 with available and evaluable data.

AUC tau: Area under the curve calculated to the end of the dosing interval ( tau) (mass\*time/volume) AUC last: Area under the curve calculated to the last quantifiable concentration point (Tlast) (mass\*time/volume)

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=1 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=7 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=3 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
n=8 Participants
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
n=19 Participants
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Eltrombopag PK Parameters: AUCtau, AUClast
AUClast
272000 hr*ng/mL
300000 hr*ng/mL
Geometric Coefficient of Variation 60.2
166000 hr*ng/mL
Geometric Coefficient of Variation 196
477000 hr*ng/mL
Geometric Coefficient of Variation 52.5
259000 hr*ng/mL
Geometric Coefficient of Variation 75.1
Eltrombopag PK Parameters: AUCtau, AUClast
AUCtau
272000 hr*ng/mL
285000 hr*ng/mL
Geometric Coefficient of Variation 72.4
406000 hr*ng/mL
502000 hr*ng/mL
Geometric Coefficient of Variation 65.6
275000 hr*ng/mL
Geometric Coefficient of Variation 52.6

PRIMARY outcome

Timeframe: at least 11 weeks after dose initiation or later when patients are taking the highest dose, up to Week 78

Population: The Number Analyzed represents the subset of participants in Pharmacokinetic Analysis Set 1 (PAS1) with available and evaluable data. PAS1 comprised all participants who provided an evaluable PK profile.

Cmax is the observed maximum plasma concentration following administration (mass/volume)

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=1 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=5 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=2 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
n=8 Participants
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
n=15 Participants
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Eltrombopag PK Parameter: Cmax
16100 ng/mL
14500 ng/mL
Geometric Coefficient of Variation 66.7
14300 ng/mL
Geometric Coefficient of Variation 56.7
27100 ng/mL
Geometric Coefficient of Variation 40.6
15600 ng/mL
Geometric Coefficient of Variation 47.2

PRIMARY outcome

Timeframe: at least 11 weeks after dose initiation or later when patients are taking the highest dose, up to Week 78

Population: The Number Analyzed represents the subset of participants in Pharmacokinetic Analysis Set 1 (PAS1) with available and evaluable data. PAS1 comprised all participants who provided an evaluable PK profile.

Ctrough is the pre-dose plasma concentration (mass/volume).

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=1 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=5 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=2 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
n=8 Participants
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
n=15 Participants
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Eltrombopag PK Parameter: Ctrough at the Highest Dose Level
5470 ng/mL
9930 ng/mL
Geometric Coefficient of Variation 68.7
9900 ng/mL
Geometric Coefficient of Variation 32.3
13400 ng/mL
Geometric Coefficient of Variation 113
9670 ng/mL
Geometric Coefficient of Variation 64.5

SECONDARY outcome

Timeframe: Week 12, Week 26, Week 52, Week 78

Population: Full analysis Set (FAS): The FAS comprised all patients to whom study treatment had been assigned.

Overall response rate (ORR) is defined as the percentage of participants who have achieved a complete response (CR) or partial response (PR) or No response (NR) by the Investigator. CR criteria: Platelet (PLT) and red blood cell (RBC) transfusion independence, Normal age-adjusted Hgb, PLT \>100 × 10\^9/L and absolute neutrophil count (ANC) \>1.5 × 10\^9/L. PR: PLT and RBC Transfusion independence and at least 2 of the following criteria: Reticulocytes \>30 × 10\^9/L, PLT \>30 × 10\^9/L, ANC \>1.5 x 10\^9L. PLT transfusion independence is defined as a period for at least 28 days without PLT transfusion. Platelet response rate (PRR): Platelet response rate is comprised of CR + PR based on the following criteria: CR: PLT \>100 × 10\^9/L; PR: PLT \>30 × 10\^9/L; NR: PLT transfusion within 4 weeks or PLT \<= 30 × 10\^9/L.

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=10 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=4 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=37 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Percentage of Participants With an Overall Response Rate and Percentage of Participants With a Platelet Response Rate Based on Per Pediatric Committee of European Medicines Agency (PDCO)
ORR: Week 12
30.0 Percentage of participants
Interval 6.7 to 65.2
50.0 Percentage of participants
Interval 6.8 to 93.2
13.5 Percentage of participants
Interval 4.5 to 28.8
—
—
Percentage of Participants With an Overall Response Rate and Percentage of Participants With a Platelet Response Rate Based on Per Pediatric Committee of European Medicines Agency (PDCO)
ORR: Week 26
70.0 Percentage of participants
Interval 34.8 to 93.3
75.0 Percentage of participants
Interval 19.4 to 99.4
45.9 Percentage of participants
Interval 29.5 to 63.1
—
—
Percentage of Participants With an Overall Response Rate and Percentage of Participants With a Platelet Response Rate Based on Per Pediatric Committee of European Medicines Agency (PDCO)
ORR: Week 52
50.0 Percentage of participants
Interval 18.7 to 81.3
50.0 Percentage of participants
Interval 6.8 to 93.2
43.2 Percentage of participants
Interval 27.1 to 60.5
—
—
Percentage of Participants With an Overall Response Rate and Percentage of Participants With a Platelet Response Rate Based on Per Pediatric Committee of European Medicines Agency (PDCO)
ORR: Week 78
50.0 Percentage of participants
Interval 18.7 to 81.3
75.0 Percentage of participants
Interval 19.4 to 99.4
40.5 Percentage of participants
Interval 24.8 to 57.9
—
—
Percentage of Participants With an Overall Response Rate and Percentage of Participants With a Platelet Response Rate Based on Per Pediatric Committee of European Medicines Agency (PDCO)
PRR: Week 12
50.0 Percentage of participants
Interval 18.7 to 81.3
75.0 Percentage of participants
Interval 19.4 to 99.4
43.2 Percentage of participants
Interval 27.1 to 60.5
—
—
Percentage of Participants With an Overall Response Rate and Percentage of Participants With a Platelet Response Rate Based on Per Pediatric Committee of European Medicines Agency (PDCO)
PRR: Week 26
60.0 Percentage of participants
Interval 26.2 to 87.8
75.0 Percentage of participants
Interval 19.4 to 99.4
54.1 Percentage of participants
Interval 36.9 to 70.5
—
—
Percentage of Participants With an Overall Response Rate and Percentage of Participants With a Platelet Response Rate Based on Per Pediatric Committee of European Medicines Agency (PDCO)
PRR: Week 52
50.0 Percentage of participants
Interval 18.7 to 81.3
75.0 Percentage of participants
Interval 19.4 to 99.4
48.6 Percentage of participants
Interval 31.9 to 65.6
—
—
Percentage of Participants With an Overall Response Rate and Percentage of Participants With a Platelet Response Rate Based on Per Pediatric Committee of European Medicines Agency (PDCO)
PRR: Week 78
50.0 Percentage of participants
Interval 18.7 to 81.3
75.0 Percentage of participants
Interval 19.4 to 99.4
45.9 Percentage of participants
Interval 29.5 to 63.1
—
—

SECONDARY outcome

Timeframe: Week 12, Week 26, Week 52, Week 78, Week 130, Week 182, Week 234

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned. For each outcome and time point, Number Analyzed represents the subset of participants in FAS with available and evaluable data at that specific visit.

Individual Platelets (PLT) and neutrophil counts were summarized for all participants.

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=10 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=4 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=37 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Hematologic Counts (Platelets (Blood), Neutrophils (Blood))
Week 234: Platelets (blood)
176.000 x 10^9 cells/L
Interval 110.0 to 196.0
129.000 x 10^9 cells/L
Interval 129.0 to 129.0
189.000 x 10^9 cells/L
Interval 147.0 to 264.0
—
—
Hematologic Counts (Platelets (Blood), Neutrophils (Blood))
Week 12: Neutrophils (blood)
1.795 x 10^9 cells/L
Interval 0.72 to 11.72
1.555 x 10^9 cells/L
Interval 1.01 to 4.15
1.100 x 10^9 cells/L
Interval 0.0 to 8.1
—
—
Hematologic Counts (Platelets (Blood), Neutrophils (Blood))
Week 26: Neutrophils (blood)
2.495 x 10^9 cells/L
Interval 0.52 to 4.6
1.258 x 10^9 cells/L
Interval 0.78 to 1.63
1.640 x 10^9 cells/L
Interval 0.4 to 4.47
—
—
Hematologic Counts (Platelets (Blood), Neutrophils (Blood))
Week 52: Neutrophils (blood)
3.110 x 10^9 cells/L
Interval 0.17 to 4.29
1.721 x 10^9 cells/L
Interval 1.11 to 3.47
2.600 x 10^9 cells/L
Interval 0.83 to 5.75
—
—
Hematologic Counts (Platelets (Blood), Neutrophils (Blood))
Week 78: Neutrophils (blood)
3.617 x 10^9 cells/L
Interval 1.02 to 4.91
1.234 x 10^9 cells/L
Interval 0.56 to 1.34
2.292 x 10^9 cells/L
Interval 0.69 to 5.41
—
—
Hematologic Counts (Platelets (Blood), Neutrophils (Blood))
Week 130: Neutrophils (blood)
2.732 x 10^9 cells/L
Interval 1.04 to 6.72
0.892 x 10^9 cells/L
Interval 0.57 to 1.21
1.690 x 10^9 cells/L
Interval 1.3 to 2.67
—
—
Hematologic Counts (Platelets (Blood), Neutrophils (Blood))
Week 182: Neutrophils (blood)
3.014 x 10^9 cells/L
Interval 1.0 to 6.09
1.471 x 10^9 cells/L
Interval 0.61 to 2.33
3.100 x 10^9 cells/L
Interval 2.07 to 4.3
—
—
Hematologic Counts (Platelets (Blood), Neutrophils (Blood))
Week 234: Neutrophils (blood)
2.630 x 10^9 cells/L
Interval 2.04 to 4.4
1.200 x 10^9 cells/L
Interval 1.2 to 1.2
2.078 x 10^9 cells/L
Interval 1.02 to 4.7
—
—
Hematologic Counts (Platelets (Blood), Neutrophils (Blood))
Week 78: Platelets (blood)
133.500 x 10^9 cells/L
Interval 6.0 to 308.0
140.000 x 10^9 cells/L
Interval 88.0 to 273.0
152.500 x 10^9 cells/L
Interval 28.0 to 278.0
—
—
Hematologic Counts (Platelets (Blood), Neutrophils (Blood))
Week 130: Platelets (blood)
155.000 x 10^9 cells/L
Interval 43.0 to 195.0
138.500 x 10^9 cells/L
Interval 128.0 to 149.0
139.000 x 10^9 cells/L
Interval 31.0 to 245.0
—
—
Hematologic Counts (Platelets (Blood), Neutrophils (Blood))
Week 182: Platelets (blood)
173.000 x 10^9 cells/L
Interval 9.0 to 221.0
149.000 x 10^9 cells/L
Interval 127.0 to 171.0
182.000 x 10^9 cells/L
Interval 104.0 to 223.0
—
—
Hematologic Counts (Platelets (Blood), Neutrophils (Blood))
Week 12: Platelets (blood)
40.500 x 10^9 cells/L
Interval 5.0 to 260.0
73.500 x 10^9 cells/L
Interval 17.0 to 172.0
50.000 x 10^9 cells/L
Interval 3.0 to 338.0
—
—
Hematologic Counts (Platelets (Blood), Neutrophils (Blood))
Week 26: Platelets (blood)
60.500 x 10^9 cells/L
Interval 3.0 to 222.0
122.500 x 10^9 cells/L
Interval 49.0 to 182.0
106.000 x 10^9 cells/L
Interval 3.0 to 230.0
—
—
Hematologic Counts (Platelets (Blood), Neutrophils (Blood))
Week 52: Platelets (blood)
147.000 x 10^9 cells/L
Interval 7.0 to 164.0
160.500 x 10^9 cells/L
Interval 22.0 to 240.0
163.000 x 10^9 cells/L
Interval 28.0 to 318.0
—
—

SECONDARY outcome

Timeframe: Week 12, Week 26, Week 52, Week 78, Week 130, Week 182, Week 234

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned. For each outcome and time point, analyses were performed using all participants in the FAS with available and evaluable data at that specific visit.

Individual hemoglobin (Hgb) counts were summarized for all participants.

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=10 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=4 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=37 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Hematologic Counts (Hemoglobin (Blood))
Week 12
89.5 g/L
Interval 64.0 to 131.0
87.0 g/L
Interval 81.0 to 94.0
88.0 g/L
Interval 57.0 to 130.0
—
—
Hematologic Counts (Hemoglobin (Blood))
Week 26
101.0 g/L
Interval 59.0 to 128.0
98.5 g/L
Interval 93.0 to 102.0
95.0 g/L
Interval 44.0 to 125.0
—
—
Hematologic Counts (Hemoglobin (Blood))
Week 52
116.0 g/L
Interval 52.0 to 138.0
104.5 g/L
Interval 95.0 to 117.0
110.0 g/L
Interval 92.0 to 133.0
—
—
Hematologic Counts (Hemoglobin (Blood))
Week 78
118.5 g/L
Interval 67.0 to 138.0
92.0 g/L
Interval 89.0 to 119.0
117.0 g/L
Interval 97.0 to 148.0
—
—
Hematologic Counts (Hemoglobin (Blood))
Week 130
119.5 g/L
Interval 88.0 to 141.0
125.5 g/L
Interval 122.0 to 129.0
126.0 g/L
Interval 109.0 to 142.0
—
—
Hematologic Counts (Hemoglobin (Blood))
Week 182
126.0 g/L
Interval 96.0 to 138.0
125.5 g/L
Interval 115.0 to 136.0
127.0 g/L
Interval 66.0 to 129.0
—
—
Hematologic Counts (Hemoglobin (Blood))
Week 234
126.0 g/L
Interval 116.0 to 147.0
128.0 g/L
Interval 128.0 to 128.0
125.0 g/L
Interval 110.0 to 144.0
—
—

SECONDARY outcome

Timeframe: From date of first dose to approx. 4.5 years

Population: The Number of Participants Analyzed reflects the Full Analysis Set (FAS), which comprised all participants to whom study treatment had been assigned. At each time point, the Number Analyzed represents the subset of participants in the FAS who had received at least one RBC transfusion up to that time point.

Number of transfusions during the treatment period refers to total number of RBC transfusions participants have received while on treatment.

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=10 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=4 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=37 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Number of Red Blood Cells (RBC) Transfusions
approx. 3 years
7.0 RBC transfusions
Interval 1.0 to 17.0
3.0 RBC transfusions
Interval 1.0 to 34.0
7.0 RBC transfusions
Interval 1.0 to 26.0
—
—
Number of Red Blood Cells (RBC) Transfusions
approx. 4.5 years
7.0 RBC transfusions
Interval 1.0 to 17.0
3.0 RBC transfusions
Interval 1.0 to 34.0
7.0 RBC transfusions
Interval 1.0 to 26.0
—
—

SECONDARY outcome

Timeframe: From date of first dose to approx. 4.5 years

Population: The Number of Participants Analyzed reflects the Full Analysis Set (FAS), which comprised all participants to whom study treatment had been assigned. At each time point, the Number Analyzed represents the subset of participants in the FAS who had received at least one RBC transfusion up to that time point.

Frequency of transfusions during the treatment period refers to number of RBC transfusions during the treatment period divided by number of months of treatment duration.

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=10 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=4 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=37 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Frequency of Red Blood Cell (RBC) Transfusions
approx. 3 years (n = 8, 3, 33)
1.5 RBC transfusions per month
Interval 0.0 to 4.0
0.2 RBC transfusions per month
Interval 0.0 to 3.0
0.9 RBC transfusions per month
Interval 0.0 to 5.0
—
—
Frequency of Red Blood Cell (RBC) Transfusions
approx. 4.5 years (n = 8, 3, 33)
1.5 RBC transfusions per month
Interval 0.0 to 4.0
0.2 RBC transfusions per month
Interval 0.0 to 3.0
0.9 RBC transfusions per month
Interval 0.0 to 5.0
—
—

SECONDARY outcome

Timeframe: From date of first dose to approx. 4.5 years

Population: The Number of Participants Analyzed reflects the Full Analysis Set (FAS), which comprised all participants to whom study treatment had been assigned. At each time point, the Number Analyzed represents the subset of participants in the FAS who had received at least one PLT transfusion up to that time point.

Number of transfusions during the treatment period refers to total number of PLT transfusions participants have received while on treatment.

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=8 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=1 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=34 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Number of Platelet (PLT) Transfusions
approx. 3 years
13.0 Platelet transfusions
Interval 3.0 to 48.0
53.0 Platelet transfusions
Interval 53.0 to 53.0
13.0 Platelet transfusions
Interval 2.0 to 65.0
—
—
Number of Platelet (PLT) Transfusions
approx. 4.5 years
13.0 Platelet transfusions
Interval 3.0 to 48.0
53.0 Platelet transfusions
Interval 53.0 to 53.0
13.0 Platelet transfusions
Interval 2.0 to 65.0
—
—

SECONDARY outcome

Timeframe: From date of first dose to approx. 4.5 years

Population: The Number of Participants Analyzed reflects the Full Analysis Set (FAS), which comprised all participants to whom study treatment had been assigned. At each time point, the Number Analyzed represents the subset of participants in the FAS who had received at least one PLT transfusion up to that time point.

Frequency of transfusions during the treatment period refers to number of PLT transfusions during the treatment period divided by number of months of treatment duration.

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=8 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=1 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=34 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Frequency of Platelet (PLT) Transfusions
approx. 3 years
2.0 Platelet transfusions per month
Interval 0.0 to 14.0
4.2 Platelet transfusions per month
Interval 4.2 to 4.2
2.0 Platelet transfusions per month
Interval 0.0 to 13.0
—
—
Frequency of Platelet (PLT) Transfusions
approx. 4.5 years
2.0 Platelet transfusions per month
Interval 0.0 to 14.0
4.2 Platelet transfusions per month
Interval 4.2 to 4.2
2.0 Platelet transfusions per month
Interval 0.0 to 13.0
—
—

SECONDARY outcome

Timeframe: From date of first dose to approx. 4.5 years

Population: The Number of Participants Analyzed reflects the Full Analysis Set (FAS), which comprised all participants to whom study treatment had been assigned. The Number Analyzed for this outcome represents the subset of participants in the FAS who achieved at least one period of RBC transfusion independence during the treatment period.

RBC transfusion independence is defined as a period of time of at least 56 days without RBC transfusion. Duration of RBC transfusion independence is defined as a period of time of at least 56 days without RBC transfusion. First transfusion duration was calculated as the date of the day before the first transfusion after baseline minus the date of first exposure eltrombopag + 1.

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=10 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=4 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=37 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Total Duration of Red Blood Cell (RBC) Transfusion Independence During the Treatment Period
approx. 3 years
355.0 days
Interval 185.0 to 860.0
430.0 days
Interval 262.0 to 558.0
267.0 days
Interval 58.0 to 1074.0
—
—
Total Duration of Red Blood Cell (RBC) Transfusion Independence During the Treatment Period
approx. 4.5 years
355.0 days
Interval 185.0 to 1637.0
430.0 days
Interval 262.0 to 558.0
267.0 days
Interval 58.0 to 1296.0
—
—

SECONDARY outcome

Timeframe: From date of first dose to approx. 4.5 years

Population: The Number of Participants Analyzed reflects the Full Analysis Set (FAS), which comprised all participants to whom study treatment had been assigned. The Number Analyzed for this outcome represents the subset of participants in the FAS who achieved at least one period of PLT transfusion independence during the treatment period.

Platelet transfusion independence during the treatment period is defined as the duration from the first day of the 28-day period without PLT transfusion until the occurrence of a PLT transfusion after the period free from any PLT transfusion. Duration of PLT transfusion independence is defined as a period of time of at least 28 days without platelet transfusion. First transfusion duration was calculated as the date of the day before the first transfusion after baseline minus the date of first exposure eltrombopag + 1.

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=10 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=4 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=37 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Total Duration of Platelet (PLT) Transfusion Independence During the Treatment Period
approx. 3 years
252.0 days
Interval 36.0 to 860.0
360.5 days
Interval 139.0 to 560.0
268.0 days
Interval 34.0 to 1100.0
—
—
Total Duration of Platelet (PLT) Transfusion Independence During the Treatment Period
approx. 4.5 years
252.0 days
Interval 36.0 to 1637.0
360.5 days
Interval 139.0 to 560.0
268.0 days
Interval 34.0 to 1322.0
—
—

SECONDARY outcome

Timeframe: From date of first dose to approx. 4.5 years

Population: The Number of Participants Analyzed reflects the Full Analysis Set (FAS), which comprised all participants to whom study treatment had been assigned. The Number Analyzed for this outcome represents the subset of participants in the FAS who achieved at least one period of RBC transfusion independence during the treatment period.

RBC transfusion independence is defined as a period of time of at least 56 days without RBC transfusion. Maximum duration of RBC transfusion independence is defined as the maximum duration among the durations of RBC transfusion independence. First transfusion duration was calculated as the date of first transfusion after baseline minus the date of first exposure eltrombopag + 1.

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=10 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=4 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=37 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Maximum Duration of Red Blood Cell (RBC) Transfusion Independence
approx. 3 years
355.0 days
Interval 185.0 to 860.0
321.0 days
Interval 262.0 to 430.0
259.0 days
Interval 58.0 to 1074.0
—
—
Maximum Duration of Red Blood Cell (RBC) Transfusion Independence
approx. 4.5 years
355.0 days
Interval 185.0 to 1637.0
321.0 days
Interval 262.0 to 430.0
262.0 days
Interval 58.0 to 1296.0
—
—

SECONDARY outcome

Timeframe: From date of first dose to approx. 4.5 years

Population: The Number of Participants Analyzed reflects the Full Analysis Set (FAS), which comprised all participants to whom study treatment had been assigned. The Number Analyzed for this outcome represents the subset of participants in the FAS who achieved at least one period of PLT transfusion independence during the treatment period.

Maximum duration of PLT transfusion independence is defined as the maximum duration among the durations of PLT transfusion independence. First transfusion duration was calculated as the date of first transfusion after baseline minus the date of first exposure eltrombopag + 1.

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=10 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=4 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=37 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Maximum Duration of Platelet (PLT) Transfusion Independence
approx. 3 years
252.0 days
Interval 36.0 to 860.0
360.5 days
Interval 64.0 to 560.0
249.5 days
Interval 34.0 to 1067.0
—
—
Maximum Duration of Platelet (PLT) Transfusion Independence
approx. 4.5 years
252.0 days
Interval 36.0 to 1637.0
360.5 days
Interval 64.0 to 560.0
249.5 days
Interval 34.0 to 1289.0
—
—

SECONDARY outcome

Timeframe: Screening, Week 26, Week 52, Week 78, Week 130, Week 182, Week 234

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned. For each outcome and time point, analyses were performed using all participants in the FAS with available and evaluable data at that specific visit.

Percentage of cells in bone marrow biopsy - a comprehensive diagnostic evaluation to distinguish between the various bone marrow disorders.

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=10 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=4 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=37 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Overall Bone Marrow Cellularity
OC: Week 78
32.5 Percentage of cells
Interval 5.0 to 50.0
50.0 Percentage of cells
Interval 50.0 to 50.0
35.0 Percentage of cells
Interval 3.0 to 70.0
—
—
Overall Bone Marrow Cellularity
OC: Week 130
45.0 Percentage of cells
Interval 40.0 to 50.0
45.0 Percentage of cells
Interval 45.0 to 45.0
40.0 Percentage of cells
Interval 10.0 to 60.0
—
—
Overall Bone Marrow Cellularity
HC: Week 26
21.0 Percentage of cells
Interval 5.0 to 45.0
25.0 Percentage of cells
Interval 15.0 to 40.0
17.5 Percentage of cells
Interval 1.0 to 50.0
—
—
Overall Bone Marrow Cellularity
HC: Week 52
30.0 Percentage of cells
Interval 30.0 to 40.0
45.0 Percentage of cells
Interval 45.0 to 45.0
27.5 Percentage of cells
Interval 2.0 to 50.0
—
—
Overall Bone Marrow Cellularity
HC: Week 78
25.0 Percentage of cells
Interval 3.0 to 40.0
40.0 Percentage of cells
Interval 40.0 to 40.0
30.0 Percentage of cells
Interval 2.0 to 50.0
—
—
Overall Bone Marrow Cellularity
HC: Week 130
35.0 Percentage of cells
Interval 30.0 to 40.0
35.0 Percentage of cells
Interval 35.0 to 35.0
35.0 Percentage of cells
Interval 8.0 to 50.0
—
—
Overall Bone Marrow Cellularity
HC: Week 182
—
—
60.0 Percentage of cells
Interval 40.0 to 80.0
—
—
Overall Bone Marrow Cellularity
HC: Week 234
45.0 Percentage of cells
Interval 25.0 to 50.0
—
37.5 Percentage of cells
Interval 20.0 to 50.0
—
—
Overall Bone Marrow Cellularity
Overall cellularity (OC): Screening
11.5 Percentage of cells
Interval 5.0 to 30.0
32.5 Percentage of cells
Interval 20.0 to 50.0
4.0 Percentage of cells
Interval 2.0 to 40.0
—
—
Overall Bone Marrow Cellularity
OC: Week 26
30.0 Percentage of cells
Interval 10.0 to 50.0
30.0 Percentage of cells
Interval 20.0 to 50.0
22.5 Percentage of cells
Interval 2.0 to 55.0
—
—
Overall Bone Marrow Cellularity
OC: Week 52
35.0 Percentage of cells
Interval 5.0 to 45.0
50.0 Percentage of cells
Interval 50.0 to 65.0
35.0 Percentage of cells
Interval 3.0 to 55.0
—
—
Overall Bone Marrow Cellularity
Hematologic cellularity (HC): Screening
5.0 Percentage of cells
Interval 1.0 to 25.0
22.5 Percentage of cells
Interval 10.0 to 45.0
1.5 Percentage of cells
Interval 1.0 to 25.0
—
—
Overall Bone Marrow Cellularity
OC: Week 182
—
—
52.5 Percentage of cells
Interval 45.0 to 60.0
—
—
Overall Bone Marrow Cellularity
OC: Week 234
52.5 Percentage of cells
Interval 30.0 to 55.0
—
47.5 Percentage of cells
Interval 25.0 to 60.0
—
—

SECONDARY outcome

Timeframe: Screening, Week, 26, Week 52, Week 78, Week 130, Week 182, Week 234

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned. For each outcome and time point, analyses were performed using all participants in the FAS with available and evaluable data at that specific visit.

Percentage of morphology (erythropoiesis, granulopoiesis, megakaryopoiesis, CD34+ (blast cells) cells in bone marrow aspirate - a comprehensive diagnostic evaluation to distinguish between the various bone marrow disorders.

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=10 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=4 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=37 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Bone Marrow Morphology
Erythroid cells: Week 130
22.0 Percentage of cells
Interval 22.0 to 22.0
15.0 Percentage of cells
Interval 15.0 to 15.0
17.0 Percentage of cells
Interval 5.0 to 32.0
—
—
Bone Marrow Morphology
Erythroid cells: Week 184
—
—
11.0 Percentage of cells
Interval 7.0 to 15.0
—
—
Bone Marrow Morphology
Erythroid cells: Screening
11.5 Percentage of cells
Interval 0.0 to 28.0
27.0 Percentage of cells
Interval 19.0 to 39.0
5.0 Percentage of cells
Interval 0.0 to 38.0
—
—
Bone Marrow Morphology
Erythroid cells: Week 26
10.0 Percentage of cells
Interval 1.0 to 25.0
12.0 Percentage of cells
Interval 2.0 to 22.0
18.0 Percentage of cells
Interval 0.0 to 55.0
—
—
Bone Marrow Morphology
Erythroid cells: Week 52
13.0 Percentage of cells
Interval 4.0 to 37.0
12.0 Percentage of cells
Interval 2.0 to 17.0
14.5 Percentage of cells
Interval 1.0 to 28.0
—
—
Bone Marrow Morphology
Erythroid cells: Week 78
14.0 Percentage of cells
Interval 5.0 to 20.0
15.0 Percentage of cells
Interval 15.0 to 15.0
20.5 Percentage of cells
Interval 4.0 to 26.0
—
—
Bone Marrow Morphology
Erythroid cells: Week 234
13.0 Percentage of cells
Interval 5.0 to 20.0
—
18.0 Percentage of cells
Interval 13.0 to 33.0
—
—
Bone Marrow Morphology
Neutrophil: Screening
33.0 Percentage of cells
Interval 1.0 to 48.0
29.5 Percentage of cells
Interval 19.0 to 48.0
8.0 Percentage of cells
Interval 0.0 to 45.0
—
—
Bone Marrow Morphology
Neutrophil cells: Week 26
52.0 Percentage of cells
Interval 34.0 to 63.0
47.0 Percentage of cells
Interval 29.0 to 66.0
50.0 Percentage of cells
Interval 17.0 to 78.0
—
—
Bone Marrow Morphology
Neutrophil: Week 52
48.5 Percentage of cells
Interval 32.0 to 59.0
62.0 Percentage of cells
Interval 57.0 to 67.0
52.5 Percentage of cells
Interval 20.0 to 76.0
—
—
Bone Marrow Morphology
Neutrophil: Week 78
43.0 Percentage of cells
Interval 4.0 to 54.0
53.0 Percentage of cells
Interval 53.0 to 53.0
52.0 Percentage of cells
Interval 34.0 to 67.0
—
—
Bone Marrow Morphology
Neutrophil cells: Week 130
44.0 Percentage of cells
Interval 44.0 to 44.0
51.0 Percentage of cells
Interval 51.0 to 51.0
53.0 Percentage of cells
Interval 39.0 to 65.0
—
—
Bone Marrow Morphology
Neutrophil cells: Week 182
—
—
31.0 Percentage of cells
Interval 5.0 to 57.0
—
—
Bone Marrow Morphology
Neutrophil cells: Week 234
43.5 Percentage of cells
Interval 30.0 to 56.0
—
33.5 Percentage of cells
Interval 25.0 to 36.0
—
—
Bone Marrow Morphology
Blast cells: Screening
0.00 Percentage of cells
Interval 0.0 to 1.0
1.0 Percentage of cells
Interval 0.0 to 5.0
0.0 Percentage of cells
Interval 0.0 to 3.0
—
—
Bone Marrow Morphology
Blast cells: Week 26
0.0 Percentage of cells
Interval 0.0 to 2.0
1.0 Percentage of cells
Interval 0.0 to 2.0
0.0 Percentage of cells
Interval 0.0 to 1.0
—
—
Bone Marrow Morphology
Blast cells: Week 52
0.0 Percentage of cells
Interval 0.0 to 1.0
1.0 Percentage of cells
Interval 0.0 to 2.0
0.0 Percentage of cells
Interval 0.0 to 1.0
—
—
Bone Marrow Morphology
Blast cells: Week 78
0.0 Percentage of cells
Interval 0.0 to 1.0
0.0 Percentage of cells
Interval 0.0 to 0.0
1.0 Percentage of cells
Interval 0.0 to 2.0
—
—
Bone Marrow Morphology
Blast cells: Week 130
0.0 Percentage of cells
Interval 0.0 to 0.0
0.0 Percentage of cells
Interval 0.0 to 0.0
1.0 Percentage of cells
Interval 0.0 to 2.0
—
—
Bone Marrow Morphology
Blast cells: Week 182
—
—
13.0 Percentage of cells
Interval 0.0 to 26.0
—
—
Bone Marrow Morphology
Blast cells: Week 234
0.0 Percentage of cells
Interval 0.0 to 2.0
—
1.0 Percentage of cells
Interval 0.0 to 2.0
—
—

SECONDARY outcome

Timeframe: Screening, Week 12, Week 26, Week 52, Week 78, Week 130, Week 182, Week 234

Population: The full analysis set (FAS) comprised all participants to whom study treatment was assigned. For each outcome and time point, analyses were performed using all participants in the FAS with available and evaluable data at that specific visit.

Number of bone marrow cytogenetics (chromosomal structure) by kryotyping and Fluorescence in situ hybridization (FISH). This is a comprehensive diagnostic evaluation to distinguish between the various bone marrow disorders.

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=10 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=4 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=37 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Bone Marrow Cytogenetics
FISH Chr 7 @ Week 12 · Normal
9 Participants
2 Participants
26 Participants
—
—
Bone Marrow Cytogenetics
FISH Chr 7 @ Week 12 · Abnormal
0 Participants
0 Participants
0 Participants
—
—
Bone Marrow Cytogenetics
FISH Chr 7 @ Week 12 · Not Available
0 Participants
0 Participants
1 Participants
—
—
Bone Marrow Cytogenetics
FISH Chr 7 @ Week 130 · Not Available
1 Participants
0 Participants
1 Participants
—
—
Bone Marrow Cytogenetics
FISH Chr 7 @ Week 182 · Abnormal
0 Participants
0 Participants
0 Participants
—
—
Bone Marrow Cytogenetics
FISH Chr 7 @ Week 182 · Not Available
0 Participants
0 Participants
0 Participants
—
—
Bone Marrow Cytogenetics
FISH Chr 7 @ Week 234 · Abnormal
0 Participants
0 Participants
0 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Week 78 · Abnormal
1 Participants
0 Participants
0 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Week 78 · Not Available
1 Participants
0 Participants
2 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Week 182 · Normal
3 Participants
1 Participants
7 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Week 234 · Not Available
0 Participants
0 Participants
0 Participants
—
—
Bone Marrow Cytogenetics
FISH Chr 7 @ Week 52 · Abnormal
0 Participants
0 Participants
0 Participants
—
—
Bone Marrow Cytogenetics
FISH Chr 7 @ Week 52 · Not Available
0 Participants
0 Participants
1 Participants
—
—
Bone Marrow Cytogenetics
FISH Chr 7 @ Week 78 · Normal
6 Participants
1 Participants
13 Participants
—
—
Bone Marrow Cytogenetics
FISH Chr 7 @ Week 78 · Abnormal
0 Participants
0 Participants
0 Participants
—
—
Bone Marrow Cytogenetics
FISH Chr 7 @ Week 78 · Not Available
0 Participants
0 Participants
2 Participants
—
—
Bone Marrow Cytogenetics
FISH Chr 7 @ Week 130 · Normal
2 Participants
1 Participants
9 Participants
—
—
Bone Marrow Cytogenetics
FISH Chr 7 @ Week 130 · Abnormal
0 Participants
0 Participants
0 Participants
—
—
Bone Marrow Cytogenetics
FISH Chr 7 @ Week 182 · Normal
3 Participants
1 Participants
8 Participants
—
—
Bone Marrow Cytogenetics
FISH Chr 7 @ Week 234 · Normal
4 Participants
0 Participants
4 Participants
—
—
Bone Marrow Cytogenetics
FISH Chr 7 @ Week 234 · Not Available
0 Participants
0 Participants
0 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Screening · Normal
8 Participants
4 Participants
19 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Screening · Abnormal
0 Participants
0 Participants
0 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Screening · Not Available
2 Participants
0 Participants
8 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Week 12 · Normal
8 Participants
2 Participants
25 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Week 12 · Abnormal
1 Participants
0 Participants
0 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Week 12 · Not Available
0 Participants
0 Participants
6 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Week 26 · Normal
7 Participants
3 Participants
25 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Week 26 · Abnormal
1 Participants
0 Participants
1 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Week 26 · Not Available
1 Participants
0 Participants
5 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Week 52 · Normal
5 Participants
3 Participants
15 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Week 52 · Abnormal
0 Participants
0 Participants
0 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Week 52 · Not Available
0 Participants
0 Participants
2 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Week 78 · Normal
4 Participants
1 Participants
13 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Week 130 · Normal
2 Participants
1 Participants
8 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Week 130 · Abnormal
0 Participants
0 Participants
0 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Week 130 · Not Available
2 Participants
0 Participants
2 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Week 182 · Abnormal
0 Participants
0 Participants
1 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Week 182 · Not Available
0 Participants
0 Participants
0 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Week 234 · Normal
4 Participants
0 Participants
4 Participants
—
—
Bone Marrow Cytogenetics
Karyotype @ Week 234 · Abnormal
0 Participants
0 Participants
0 Participants
—
—
Bone Marrow Cytogenetics
FISH Chr 7 @ Screening · Normal
10 Participants
4 Participants
26 Participants
—
—
Bone Marrow Cytogenetics
FISH Chr 7 @ Screening · Abnormal
0 Participants
0 Participants
0 Participants
—
—
Bone Marrow Cytogenetics
FISH Chr 7 @ Screening · Not Available
0 Participants
0 Participants
2 Participants
—
—
Bone Marrow Cytogenetics
FISH Chr 7 @ Week 26 · Normal
8 Participants
3 Participants
28 Participants
—
—
Bone Marrow Cytogenetics
FISH Chr 7 @ Week 26 · Abnormal
0 Participants
0 Participants
0 Participants
—
—
Bone Marrow Cytogenetics
FISH Chr 7 @ Week 26 · Not Available
1 Participants
0 Participants
1 Participants
—
—
Bone Marrow Cytogenetics
FISH Chr 7 @ Week 52 · Normal
6 Participants
3 Participants
15 Participants
—
—

SECONDARY outcome

Timeframe: any day from Day 1 of drug initiation up to Week 78

Population: The Number of Participants Analyzed reflects the Full Analysis Set (FAS), which comprised of all participants to whom study treatment had been assigned. The Number Analyzed for each score represents the subset of participants in the FAS who received that specific formulation and provided questionnaire feedback. There were no participants in Cohort A who took the Powder for Oral Solution (PfOS) formulation that provided questionnaire feedback on Acceptability (including palatability).

Standardized (total) summary score, ranged from 0-100, (where 0 means worst and 100 means the best), was derived from all items from the questionnaire based on a scoring matrix. The questionnaire was completed by parents and caregivers of patients under 12 years of age (ObsRO) and a questionnaire completed by patients 12 years and older (PRO).

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=5 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=3 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=16 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Acceptability and Palatability for Both Tablets and Powder Formulation for Oral Solution (PfOS)
Acceptability (including palatability) - Tablet
71.0 scores on a scale (of acceptability)
Interval 58.0 to 96.0
75.0 scores on a scale (of acceptability)
Interval 58.0 to 88.0
71.0 scores on a scale (of acceptability)
Interval 46.0 to 96.0
—
—
Acceptability and Palatability for Both Tablets and Powder Formulation for Oral Solution (PfOS)
Acceptability (including palatability) - PfOS
—
—
71.0 scores on a scale (of acceptability)
Interval 32.0 to 82.0
—
—

SECONDARY outcome

Timeframe: Baseline, Week (W) 26 Day (D) 1, W52D1, W78D1, W130D1, W182D1, W234D1

Population: Full analysis Set (FAS): The FAS comprised all patients to whom study treatment had been assigned excluding recurrent SAA participants.

Percentage of participants with clonal evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH).

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=10 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=4 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=37 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH)
W130D1: Negative clonal evolution
30.0 Percentage of participants
0 Percentage of participants
8.1 Percentage of participants
—
—
Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH)
W130D1: Missing
70.0 Percentage of participants
100.0 Percentage of participants
91.9 Percentage of participants
—
—
Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH)
W182D1: Positive clonal evolution
10.0 Percentage of participants
0 Percentage of participants
2.7 Percentage of participants
—
—
Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH)
W182D1: Negative clonal evolution
20.0 Percentage of participants
0 Percentage of participants
8.1 Percentage of participants
—
—
Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH)
W182D1: Missing
70.0 Percentage of participants
100.0 Percentage of participants
89.2 Percentage of participants
—
—
Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH)
W234D1: Positive clonal evolution
0 Percentage of participants
0 Percentage of participants
2.7 Percentage of participants
—
—
Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH)
W234D1: Negative clonal evolution
30.0 Percentage of participants
0 Percentage of participants
2.7 Percentage of participants
—
—
Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH)
W234D1: Missing
70.0 Percentage of participants
100.0 Percentage of participants
94.6 Percentage of participants
—
—
Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH)
Baseline: Positive clonal evolution
20.0 Percentage of participants
25.0 Percentage of participants
29.7 Percentage of participants
—
—
Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH)
W26D1: Positive clonal evolution
10.0 Percentage of participants
50.0 Percentage of participants
8.1 Percentage of participants
—
—
Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH)
W26D1: Negative clonal evolution
80.0 Percentage of participants
25.0 Percentage of participants
64.9 Percentage of participants
—
—
Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH)
W52D1: Missing
70.0 Percentage of participants
50.0 Percentage of participants
67.6 Percentage of participants
—
—
Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH)
W78D1: Positive clonal evolution
0 Percentage of participants
25.0 Percentage of participants
0 Percentage of participants
—
—
Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH)
W130D1: Positive clonal evolution
0 Percentage of participants
0 Percentage of participants
0 Percentage of participants
—
—
Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH)
W78D1: Missing
60.0 Percentage of participants
50.0 Percentage of participants
78.4 Percentage of participants
—
—
Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH)
Baseline: Negative clonal evolution
80.0 Percentage of participants
75.0 Percentage of participants
64.9 Percentage of participants
—
—
Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH)
Baseline: Missing
0.0 Percentage of participants
0.0 Percentage of participants
5.4 Percentage of participants
—
—
Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH)
W26D1: Missing
10.0 Percentage of participants
25.0 Percentage of participants
27.0 Percentage of participants
—
—
Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH)
W52D1: Positive clonal evolution
0 Percentage of participants
25.0 Percentage of participants
2.7 Percentage of participants
—
—
Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH)
W52D1: Negative clonal evolution
30.0 Percentage of participants
25.0 Percentage of participants
29.7 Percentage of participants
—
—
Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH)
W78D1: Negative clonal evolution
40.0 Percentage of participants
25.0 Percentage of participants
21.6 Percentage of participants
—
—

SECONDARY outcome

Timeframe: at least 11 weeks after dose initiation or later when patients are taking the highest dose, up to Week 78

Population: Pharmacokinetic Analysis Set 1 (PAS1) included all participants who provided an evaluable PK profile. For this exposure-response analysis, the Overall Number of Participants Analyzed represents participants in PAS1 with evaluable PK data and an evaluable response classification for the relevant response category. The Number Analyzed for each row represents the subset classified as No Response, Complete Response, or Partial Response.

Pharmacokinetic parameter (AUCtau) of eltrombopag at the highest dose in relationship to best overall response rate in regard to complete response (CR), partial response (PR) and no response (NR). AUC tau: Area under the curve calculated to the end of the dosing interval (tau) (mass\*time/volume)

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=1 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=4 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=1 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
n=6 Participants
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
n=10 Participants
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Exposure (AUCtau) - Response Relationship of Eltrombopag and Best Overall Response Rate by Age Groups
No response (NR)
816000 hr*ng/mL
390000 hr*ng/mL
—
1260000 hr*ng/mL
Geometric Coefficient of Variation 27.0
—
Exposure (AUCtau) - Response Relationship of Eltrombopag and Best Overall Response Rate by Age Groups
Partial response (PR)
—
—
1220000 hr*ng/mL
671000 hr*ng/mL
963000 hr*ng/mL
Geometric Coefficient of Variation 80.6
Exposure (AUCtau) - Response Relationship of Eltrombopag and Best Overall Response Rate by Age Groups
Complete response (CR)
—
769000 hr*ng/mL
Geometric Coefficient of Variation 87.3
—
2260000 hr*ng/mL
503000 hr*ng/mL
Geometric Coefficient of Variation 57.4

SECONDARY outcome

Timeframe: at least 11 weeks after dose initiation or later when patients are taking the highest dose, up to Week 78

Population: Pharmacokinetic Analysis Set 1 (PAS1) included all participants who provided an evaluable PK profile. For this exposure-response analysis, the Overall Number of Participants Analyzed represents participants in PAS1 with evaluable PK data and an evaluable response classification for the relevant response category. The Number Analyzed for each row represents the subset classified as No Response, Complete Response, or Partial Response.

Pharmacokinetic parameters (Cmax and Ctrough) of eltrombopag at the highest dose in relationship to overall response rate in regard to complete response (CR), partial response (PR) and no response (NR). Cmax is the observed maximum plasma concentration following administration (mass/volume). Ctrough is the pre-dose plasma concentration (mass/volume).

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=1 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=5 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=2 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
n=8 Participants
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
n=15 Participants
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Exposure (Cmax, Ctrough) - Response Relationship of Eltrombopag and Best Overall Response Rate by Age Groups
Cmax: No Response
48400 ng/mL
Geometric Coefficient of Variation 0
33900 ng/mL
Geometric Coefficient of Variation 115
—
84900 ng/mL
Geometric Coefficient of Variation 32.6
39200 ng/mL
Geometric Coefficient of Variation 33.1
Exposure (Cmax, Ctrough) - Response Relationship of Eltrombopag and Best Overall Response Rate by Age Groups
Cmax: Partial Response
—
—
24800 ng/mL
Geometric Coefficient of Variation 212
60500 ng/mL
Geometric Coefficient of Variation 26.6
54000 ng/mL
Geometric Coefficient of Variation 54.4
Exposure (Cmax, Ctrough) - Response Relationship of Eltrombopag and Best Overall Response Rate by Age Groups
Ctrough: No Response
16400 ng/mL
19900 ng/mL
Geometric Coefficient of Variation 106
—
37800 ng/mL
Geometric Coefficient of Variation 32.6
18500 ng/mL
Geometric Coefficient of Variation 43.6
Exposure (Cmax, Ctrough) - Response Relationship of Eltrombopag and Best Overall Response Rate by Age Groups
Ctrough: Partial Response
—
—
17100 ng/mL
Geometric Coefficient of Variation 151
23800 ng/mL
Geometric Coefficient of Variation 194
35300 ng/mL
Geometric Coefficient of Variation 65.9
Exposure (Cmax, Ctrough) - Response Relationship of Eltrombopag and Best Overall Response Rate by Age Groups
Cmax: Complete Response
—
35700 ng/mL
Geometric Coefficient of Variation 88.3
—
112000 ng/mL
31200 ng/mL
Geometric Coefficient of Variation 63.7
Exposure (Cmax, Ctrough) - Response Relationship of Eltrombopag and Best Overall Response Rate by Age Groups
Ctrough: Complete Response
—
27000 ng/mL
Geometric Coefficient of Variation 104
—
84700 ng/mL
20100 ng/mL
Geometric Coefficient of Variation 72.8

SECONDARY outcome

Timeframe: at least 11 weeks after dose initiation or later when patients are taking the highest dose, up to Week 78

Population: Pharmacokinetic Analysis Set 1 (PAS1) included all participants who provided an evaluable PK profile. The Number Analyzed for each response category represents the subset of participants in PAS1 who achieved that specific response (Complete Response, Partial Response, or No Response).

Pharmacokinetic parameter (AUCtau) of eltrombopag at the highest dose in relationship to platelet response rate. AUC tau: Area under the curve calculated to the end of the dosing interval ( tau) (mass\*time/volume)

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=1 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=4 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=1 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
n=6 Participants
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
n=10 Participants
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Exposure (AUCtau) - Response Relationship of Eltrombopag and Best Platelet Response Rate by Age Groups
No Response
816000 hr*ng/mL
—
—
—
1280000 hr*ng/mL
Exposure (AUCtau) - Response Relationship of Eltrombopag and Best Platelet Response Rate by Age Groups
Complete Response
—
769000 hr*ng/mL
Geometric Coefficient of Variation 87.3
1220000 hr*ng/mL
1670000 hr*ng/mL
Geometric Coefficient of Variation 45.2
563000 hr*ng/mL
Geometric Coefficient of Variation 67.3
Exposure (AUCtau) - Response Relationship of Eltrombopag and Best Platelet Response Rate by Age Groups
Partial Response
—
390000 hr*ng/mL
—
1090000 hr*ng/mL
Geometric Coefficient of Variation 43.5
—

SECONDARY outcome

Timeframe: at least 11 weeks after dose initiation or later when patients are taking the highest dose, up to Week 78

Population: Pharmacokinetic Analysis Set 1 (PAS1) included all participants who provided an evaluable PK profile. The Number Analyzed for each response category represents the subset of participants in PAS1 who achieved that specific response (Complete Response, Partial Response, or No Response).

Pharmacokinetic parameters (Cmax and Ctrough) of eltrombopag at the highest dose in relationship to platelet response rate. Cmax is the observed maximum plasma concentration following administration (mass/volume). Ctrough is the pre-dose plasma concentration (mass/volume).

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=1 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=5 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=2 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
n=8 Participants
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
n=15 Participants
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Exposure (Cmax, Ctrough) - Response Relationship of Eltrombopag and Best Platelet Response Rate by Age Groups
Cmax: No Response
48400 ng/mL
64900 ng/mL
—
—
66600 ng/mL
Exposure (Cmax, Ctrough) - Response Relationship of Eltrombopag and Best Platelet Response Rate by Age Groups
Cmax: Complete Response
—
35700 ng/mL
Geometric Coefficient of Variation 88.3
24800 ng/mL
Geometric Coefficient of Variation 212
80900 ng/mL
Geometric Coefficient of Variation 31.7
35200 ng/mL
Geometric Coefficient of Variation 65.8
Exposure (Cmax, Ctrough) - Response Relationship of Eltrombopag and Best Platelet Response Rate by Age Groups
Cmax: Partial Response
—
17700 ng/mL
—
74000 ng/mL
Geometric Coefficient of Variation 42.1
39200 ng/mL
Geometric Coefficient of Variation 33.1
Exposure (Cmax, Ctrough) - Response Relationship of Eltrombopag and Best Platelet Response Rate by Age Groups
Ctrough: No Response
16400 ng/mL
1 ng/mL
Geometric Coefficient of Variation 36800
—
—
45000 ng/mL
Exposure (Cmax, Ctrough) - Response Relationship of Eltrombopag and Best Platelet Response Rate by Age Groups
Ctrough: Complete Response
—
27000 ng/mL
Geometric Coefficient of Variation 104
17100 ng/mL
Geometric Coefficient of Variation 151
50100 ng/mL
Geometric Coefficient of Variation 48.6
22700 ng/mL
Geometric Coefficient of Variation 75.3
Exposure (Cmax, Ctrough) - Response Relationship of Eltrombopag and Best Platelet Response Rate by Age Groups
Ctrough: Partial Response
—
10800 ng/mL
—
24600 ng/mL
Geometric Coefficient of Variation 132
18500 ng/mL
Geometric Coefficient of Variation 43.6

SECONDARY outcome

Timeframe: Week 12, Week 26, Week 52, Week 78

Population: Full analysis Set (FAS): The FAS comprised all patients to whom study treatment had been assigned.

Alternate overall responses were derived using hematological parameters (i.e., hemoglobin, platelet, reticulocyte, and ANC). aORR is defined as the percentage of participants who achieved an alternate complete response (aCR) or an alternate partial response (aPR)

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=10 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=4 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=37 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Alternate Overall Response Rate (aORR)
Week 12
90.0 Percentage of participants
Interval 55.5 to 99.7
100 Percentage of participants
Interval 39.8 to 100.0
64.9 Percentage of participants
Interval 47.5 to 79.8
—
—
Alternate Overall Response Rate (aORR)
Week 26
90.0 Percentage of participants
Interval 55.5 to 99.7
100 Percentage of participants
Interval 39.8 to 100.0
75.7 Percentage of participants
Interval 58.8 to 88.2
—
—
Alternate Overall Response Rate (aORR)
Week 52
60.0 Percentage of participants
Interval 26.2 to 87.8
100 Percentage of participants
Interval 39.8 to 100.0
40.5 Percentage of participants
Interval 24.8 to 57.9
—
—
Alternate Overall Response Rate (aORR)
Week 78
50.0 Percentage of participants
Interval 18.7 to 81.3
75.0 Percentage of participants
Interval 19.4 to 99.4
48.6 Percentage of participants
Interval 31.9 to 65.6
—
—

SECONDARY outcome

Timeframe: Week 3 Day 1

Population: The Number Analyzed represents the subset of participants in Pharmacokinetic Analysis Set 1 (PAS1) with available and evaluable data. PAS1 comprised all participants who provided an evaluable PK profile.

PK parameter, AUCtau. AUC tau: Area under the curve calculated to the end of the dosing interval (tau) (mass\*time/volume)

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=5 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=3 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=12 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
Pharmacokinetics (PK) of Eltrombopag at the Starting Dose (AUCtau)
367000 hr*ng/mL
Geometric Coefficient of Variation 35.6
350000 hr*ng/mL
Geometric Coefficient of Variation 47.7
441000 hr*ng/mL
Geometric Coefficient of Variation 55.2
—
—

SECONDARY outcome

Timeframe: Week 3 Day 1

Population: The Number Analyzed represents the subset of participants in Pharmacokinetic Analysis Set 1 (PAS1) with available and evaluable data. PAS1 comprised all participants who provided an evaluable PK profile.

PK parameter, Cmax Cmax is the observed maximum plasma concentration following administration (mass/volume)

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=6 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=3 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=16 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
PK of Eltrombopag at the Starting Dose (Cmax)
19700 ng/mL
Geometric Coefficient of Variation 46.5
21000 ng/mL
Geometric Coefficient of Variation 24.5
24000 ng/mL
Geometric Coefficient of Variation 51.0
—
—

SECONDARY outcome

Timeframe: Week 3 Day 1

Population: The Number Analyzed represents the subset of participants in Pharmacokinetic Analysis Set 1 (PAS1) with available and evaluable data. PAS1 comprised all participants who provided an evaluable PK profile.

PK parameter, Ctrough Ctrough is the pre-dose plasma concentration (mass/volume).

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=6 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=3 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=16 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
PK of Eltrombopag at the Starting Dose (Ctrough)
8760 ng/mL
Geometric Coefficient of Variation 72.9
10900 ng/mL
Geometric Coefficient of Variation 66.6
13200 ng/mL
Geometric Coefficient of Variation 52.2
—
—

POST_HOC outcome

Timeframe: On-treatment deaths: from first dose of study treatment up to 30 days post treatment, approx. 234 weeks; Post-treatment survival follow-up deaths: from Day 31 to approx. 234 weeks

Population: Clinical database population: all treated participants; participants who were treated up to data cut-off date until date of the last follow-up for the primary analysis, up to 234 weeks

On-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication, for a maximum duration of 234 weeks. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until date of the last follow-up for the primary analysis, up to 234 weeks.

Outcome measures

Outcome measures
Measure
Cohort A: Regimen 1 (1 to <6 Years)
n=10 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 1 (6 to <18 Years)
n=4 Participants
Participants received hATG (ATGAM®), CsA and eltrombopag beginning on Day 1.
Cohort A: Regimen 2 (6 to <18 Years)
n=37 Participants
Participants received CsA and eltrombopag beginning on Day 1.
Cohort B (1 to < 6 Years)
n=51 Participants
Previously untreated SAA, hATG (ATGAM®), CsA and eltrombopag begin on Day 1 and all patients will be treated with the same regimen
Cohort B (6 to <18 Years)
Participants who previously had untreated SAA received hATG, CsA and eltrombopag beginning on Day 1.
All Collected Deaths
Total deaths
0 Participants
1 Participants
0 Participants
1 Participants
—
All Collected Deaths
Post-treatment deaths
0 Participants
1 Participants
0 Participants
1 Participants
—
All Collected Deaths
On-treatment deaths
0 Participants
0 Participants
0 Participants
0 Participants
—

Adverse Events

Cohort A - Regimen 1 (On-treatment)

Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths

Cohort A - Regimen 2 (On-treatment)

Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths

Total Cohort A (Regiments 1 & 2) (On-treatment)

Serious events: 6 serious events
Other events: 14 other events
Deaths: 0 deaths

Cohort B (On-treatment)

Serious events: 23 serious events
Other events: 37 other events
Deaths: 0 deaths

Total Participants (On-treatment)

Serious events: 29 serious events
Other events: 51 other events
Deaths: 0 deaths

Cohort A - Regimen 1 (Post--treatment)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Cohort A - Regimen 2 (Post-treatment)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

Total Cohort A (Regimens 1 & 2) (Post-treatment)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

Cohort B (Post-treatment)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

All Participants (Cohorts A & B) (Post-treatment)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Cohort A - Regimen 1 (On-treatment)
n=10 participants at risk
On-treatment period: from first dose of study treatment up to 30 days post-treatment
Cohort A - Regimen 2 (On-treatment)
n=4 participants at risk
On-treatment period: from first dose of study treatment up to 30 days post-treatment
Total Cohort A (Regiments 1 & 2) (On-treatment)
n=14 participants at risk
On-treatment period: from first dose of study treatment up to 30 days post-treatment
Cohort B (On-treatment)
n=37 participants at risk
On-treatment period from first dose of study treatment up to 30 days post-treatment
Total Participants (On-treatment)
n=51 participants at risk
On-treatment period: from first dose of study treatment up to 30 days post-treatment
Cohort A - Regimen 1 (Post--treatment)
Post-treatment period: from Day 31 up to Week 234
Cohort A - Regimen 2 (Post-treatment)
Post-treatment period: from Day 31 up to Week 234
Total Cohort A (Regimens 1 & 2) (Post-treatment)
Post-treatment period: from Day 31 up to Week 234
Cohort B (Post-treatment)
Post-treatment period: from Day 31 up to Week 234
All Participants (Cohorts A & B) (Post-treatment)
Post-treatment period: from Day 31 up to Week 234
Blood and lymphatic system disorders
Febrile neutropenia
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
14.3%
2/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
13.5%
5/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
13.7%
7/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Abdominal pain
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Dysphagia
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Gingival pain
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Ileus
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Stomatitis
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
General disorders
Fatigue
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
General disorders
Pyrexia
20.0%
2/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
21.4%
3/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
21.6%
8/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
21.6%
11/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Hepatobiliary disorders
Drug-induced liver injury
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Immune system disorders
Serum sickness
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Anal abscess
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Appendicitis
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Bacillus bacteraemia
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Bronchiolitis
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Clostridium difficile infection
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Device related infection
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Gastroenteritis
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Herpes simplex
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Klebsiella sepsis
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Metapneumovirus infection
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Respiratory syncytial virus infection
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Sepsis
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Septic shock
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Staphylococcal bacteraemia
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Staphylococcal infection
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Subcutaneous abscess
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Tonsillitis
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Varicella
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Injury, poisoning and procedural complications
Post procedural haemorrhage
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Injury, poisoning and procedural complications
Sunburn
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Injury, poisoning and procedural complications
Toxicity to various agents
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Investigations
Blood creatinine increased
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Investigations
Liver function test increased
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Investigations
Platelet count decreased
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Dehydration
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Electrolyte imbalance
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Hypomagnesaemia
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Magnesium metabolism disorder
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Nervous system disorders
Headache
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Product Issues
Device malfunction
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Renal and urinary disorders
Acute kidney injury
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.9%
3/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Renal and urinary disorders
Azotaemia
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Renal and urinary disorders
Haematuria
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Renal and urinary disorders
Renal failure
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Reproductive system and breast disorders
Abnormal uterine bleeding
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Respiratory, thoracic and mediastinal disorders
Tonsillar exudate
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Skin and subcutaneous tissue disorders
Petechiae
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Vascular disorders
Hypertension
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.

Other adverse events

Other adverse events
Measure
Cohort A - Regimen 1 (On-treatment)
n=10 participants at risk
On-treatment period: from first dose of study treatment up to 30 days post-treatment
Cohort A - Regimen 2 (On-treatment)
n=4 participants at risk
On-treatment period: from first dose of study treatment up to 30 days post-treatment
Total Cohort A (Regiments 1 & 2) (On-treatment)
n=14 participants at risk
On-treatment period: from first dose of study treatment up to 30 days post-treatment
Cohort B (On-treatment)
n=37 participants at risk
On-treatment period from first dose of study treatment up to 30 days post-treatment
Total Participants (On-treatment)
n=51 participants at risk
On-treatment period: from first dose of study treatment up to 30 days post-treatment
Cohort A - Regimen 1 (Post--treatment)
Post-treatment period: from Day 31 up to Week 234
Cohort A - Regimen 2 (Post-treatment)
Post-treatment period: from Day 31 up to Week 234
Total Cohort A (Regimens 1 & 2) (Post-treatment)
Post-treatment period: from Day 31 up to Week 234
Cohort B (Post-treatment)
Post-treatment period: from Day 31 up to Week 234
All Participants (Cohorts A & B) (Post-treatment)
Post-treatment period: from Day 31 up to Week 234
Blood and lymphatic system disorders
Aplastic anaemia
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Blood and lymphatic system disorders
Febrile neutropenia
20.0%
2/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
21.4%
3/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
21.6%
8/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
21.6%
11/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Blood and lymphatic system disorders
Haemolysis
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Blood and lymphatic system disorders
Lymphadenopathy
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Cardiac disorders
Tachycardia
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.9%
3/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Ear and labyrinth disorders
Ear pain
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Endocrine disorders
Adrenal insufficiency
20.0%
2/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
14.3%
2/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.9%
3/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Endocrine disorders
Cushingoid
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Eye disorders
Accommodation disorder
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Eye disorders
Choroidal effusion
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Eye disorders
Conjunctival haemorrhage
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Eye disorders
Dry eye
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Eye disorders
Eye pain
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Abdominal distension
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Abdominal pain
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
50.0%
2/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
21.4%
3/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
35.1%
13/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
31.4%
16/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
13.5%
5/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
11.8%
6/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Anal haemorrhage
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Aphthous ulcer
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Chronic gastritis
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Constipation
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
13.5%
5/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
9.8%
5/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Diarrhoea
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
24.3%
9/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
19.6%
10/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Enterocolitis
20.0%
2/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
14.3%
2/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
8.1%
3/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
9.8%
5/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Gastritis
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Gingival bleeding
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
13.5%
5/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
11.8%
6/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Gingival hypertrophy
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
75.0%
3/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
21.4%
3/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
10.8%
4/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
13.7%
7/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Gingival pain
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Gingival swelling
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
8.1%
3/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.9%
3/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Haematochezia
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Mouth ulceration
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Mucous stools
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Nausea
20.0%
2/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
21.4%
3/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
45.9%
17/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
39.2%
20/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Odynophagia
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Oral blood blister
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Oral pain
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Periodontal disease
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Small intestinal obstruction
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Stomatitis
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
14.3%
2/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
16.2%
6/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
15.7%
8/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Tongue ulceration
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Gastrointestinal disorders
Vomiting
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
50.0%
2/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
21.4%
3/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
48.6%
18/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
41.2%
21/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
General disorders
Catheter site pain
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
General disorders
Chills
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
8.1%
3/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.8%
4/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
General disorders
Face oedema
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
General disorders
Fatigue
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
13.5%
5/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
9.8%
5/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
General disorders
Feeling hot
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
General disorders
Non-cardiac chest pain
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.9%
3/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
General disorders
Oedema peripheral
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
General disorders
Pain
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.9%
3/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
General disorders
Pyrexia
30.0%
3/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
28.6%
4/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
27.0%
10/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
27.5%
14/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Hepatobiliary disorders
Hyperbilirubinaemia
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.9%
3/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Hepatobiliary disorders
Jaundice
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Hepatobiliary disorders
Ocular icterus
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Immune system disorders
Anaphylactic shock
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Immune system disorders
Haemophagocytic lymphohistiocytosis
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Immune system disorders
Serum sickness
20.0%
2/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
14.3%
2/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
16.2%
6/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
15.7%
8/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Bacterial disease carrier
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
COVID-19
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Epididymitis
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Escherichia bacteraemia
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Fungal infection
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Gingivitis
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Molluscum contagiosum
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Nasopharyngitis
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Paronychia
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Pharyngitis
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.9%
3/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Respiratory tract infection viral
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Rhinitis
30.0%
3/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
21.4%
3/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
9.8%
5/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Soft tissue infection
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Tonsillitis
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
10.8%
4/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
9.8%
5/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Upper respiratory tract infection
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
21.6%
8/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
17.6%
9/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Infections and infestations
Vascular device infection
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Injury, poisoning and procedural complications
Accidental overdose
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Injury, poisoning and procedural complications
Contusion
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
14.3%
2/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
8.1%
3/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
9.8%
5/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Injury, poisoning and procedural complications
Infusion related reaction
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Injury, poisoning and procedural complications
Procedural pain
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Injury, poisoning and procedural complications
Refractoriness to platelet transfusion
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Injury, poisoning and procedural complications
Transfusion reaction
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Investigations
Alanine aminotransferase increased
70.0%
7/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
57.1%
8/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
43.2%
16/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
47.1%
24/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Investigations
Aspartate aminotransferase increased
60.0%
6/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
50.0%
7/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
35.1%
13/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
39.2%
20/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Investigations
Blood alkaline phosphatase increased
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
14.3%
2/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.9%
3/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Investigations
Blood bilirubin increased
60.0%
6/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
42.9%
6/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
48.6%
18/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
47.1%
24/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Investigations
Blood creatinine increased
50.0%
5/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
50.0%
2/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
50.0%
7/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
35.1%
13/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
39.2%
20/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Investigations
Blood folate decreased
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Investigations
Blood glucose increased
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Investigations
Blood magnesium decreased
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Investigations
Blood phosphorus increased
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Investigations
Blood pressure increased
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
13.5%
5/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
11.8%
6/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Investigations
Blood urea increased
40.0%
4/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
75.0%
3/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
50.0%
7/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
13.5%
5/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
23.5%
12/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Investigations
Immunosuppressant drug level increased
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Investigations
Klebsiella test positive
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Investigations
Liver function test increased
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Investigations
SARS-CoV-2 test negative
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Investigations
Serum ferritin increased
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Investigations
Staphylococcus test positive
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
13.5%
5/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
11.8%
6/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Dehydration
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Fluid retention
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Hyperglycaemia
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
8.1%
3/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.8%
4/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Hyperkalaemia
20.0%
2/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
14.3%
2/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.8%
4/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Hypermagnesaemia
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Hypervolaemia
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Hypokalaemia
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
10.8%
4/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
9.8%
5/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Hypomagnesaemia
30.0%
3/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
28.6%
4/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
40.5%
15/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
37.3%
19/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Hyponatraemia
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
14.3%
2/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.9%
3/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Iron deficiency
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Iron overload
20.0%
2/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
14.3%
2/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
10.8%
4/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
11.8%
6/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Metabolic acidosis
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
14.3%
2/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Metabolism and nutrition disorders
Vitamin D deficiency
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.9%
3/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Musculoskeletal and connective tissue disorders
Arthralgia
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
14.3%
2/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
10.8%
4/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
11.8%
6/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Musculoskeletal and connective tissue disorders
Back pain
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
14.3%
2/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.8%
4/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Musculoskeletal and connective tissue disorders
Kyphosis
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Musculoskeletal and connective tissue disorders
Pain in extremity
20.0%
2/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
50.0%
2/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
28.6%
4/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
13.5%
5/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
17.6%
9/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Musculoskeletal and connective tissue disorders
Tendon pain
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Nervous system disorders
Dizziness
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Nervous system disorders
Headache
20.0%
2/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
14.3%
2/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
21.6%
8/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
19.6%
10/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Nervous system disorders
Syncope
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Nervous system disorders
Tremor
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Psychiatric disorders
Anxiety
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
13.5%
5/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
9.8%
5/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Psychiatric disorders
Insomnia
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
8.1%
3/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.9%
3/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Psychiatric disorders
Psychotic disorder
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Renal and urinary disorders
Acute kidney injury
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
14.3%
2/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
8.1%
3/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
9.8%
5/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Renal and urinary disorders
Azotaemia
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Renal and urinary disorders
Nephropathy toxic
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Renal and urinary disorders
Paroxysmal nocturnal haemoglobinuria
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Renal and urinary disorders
Renal failure
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Renal and urinary disorders
Renal impairment
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Renal and urinary disorders
Renal tubular acidosis
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Reproductive system and breast disorders
Heavy menstrual bleeding
20.0%
2/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
14.3%
2/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.9%
3/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Respiratory, thoracic and mediastinal disorders
Cough
20.0%
2/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
14.3%
2/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
8.1%
3/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
9.8%
5/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Respiratory, thoracic and mediastinal disorders
Epistaxis
20.0%
2/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
21.4%
3/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
13.5%
5/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
15.7%
8/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Respiratory, thoracic and mediastinal disorders
Laryngospasm
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
8.1%
3/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.8%
4/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
14.3%
2/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
8.1%
3/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
9.8%
5/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Respiratory, thoracic and mediastinal disorders
Tonsillar exudate
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Skin and subcutaneous tissue disorders
Acne
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
3.9%
2/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Skin and subcutaneous tissue disorders
Ecchymosis
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
50.0%
2/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
14.3%
2/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.7%
1/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.9%
3/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Skin and subcutaneous tissue disorders
Hirsutism
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
50.0%
2/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
14.3%
2/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
8.1%
3/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
9.8%
5/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Skin and subcutaneous tissue disorders
Petechiae
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
50.0%
2/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
14.3%
2/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
8.1%
3/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
9.8%
5/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
10.8%
4/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
9.8%
5/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Skin and subcutaneous tissue disorders
Rash
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
27.0%
10/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
21.6%
11/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Skin and subcutaneous tissue disorders
Rash maculo-papular
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
14.3%
2/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.8%
4/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Skin and subcutaneous tissue disorders
Rash papular
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
20.0%
2/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
14.3%
2/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.8%
4/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Skin and subcutaneous tissue disorders
Urticaria
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
16.2%
6/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
13.7%
7/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Vascular disorders
Hyperaemia
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Vascular disorders
Hypertension
40.0%
4/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
35.7%
5/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
40.5%
15/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
39.2%
20/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Vascular disorders
Hypotension
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.4%
2/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
5.9%
3/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Vascular disorders
Poor peripheral circulation
0.00%
0/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
25.0%
1/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
Vascular disorders
Thrombophlebitis
10.0%
1/10 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/4 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
7.1%
1/14 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
0.00%
0/37 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
2.0%
1/51 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.
—
0/0 • Adverse Events (AEs) were collected from first dosing (Day 1) until date of the last follow-up, up to 30 weeks. Deaths were collected from randomization to end of study, up to 234 weeks.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporarily or causally associated with the use of a medicinal (investigational) product. Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed during the post-treatment period.

Additional Information

Clinical Disclosure Office

Novartis Pharmaceuticals

Phone: 862-778-3000

Results disclosure agreements

  • Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e., data from all sites) in clinical trial or disclosure of trial results in their entirety.
  • Publication restrictions are in place

Restriction type: OTHER